| Manufacturer Safety Alerts
Explant Return Process Performance Reports |
2008
Society Members Collaborate with the FDA at Pacemaker and ICD Lead Workshop (10/08/2008)— Bruce Wilkoff, MD, FHRS; William Maisel, MD and Andrew Krahn, MD represented the Society as participants in the U.S. Food and Drug Administration’s Workshop on Best Practices for Pacemaker and ICD Lead Postmarket Surveillance on October 2-3, 2008. They emphasized the importance of post-market surveillance, the risk versus benefit of lead extraction for return product analysis, the importance of follow-up and communicating adverse events in a timely manner and benefits of registries and home monitoring systems for reporting essential information in their presentations. Learn more »
Heart Rhythm Society Continues to Influence FDA Risk Advisory Notices (02/29/2008) — On February 29, the Heart Rhythm Society presented a statement from our recommendations in the 2006 Device Performance Policies and Guidelines document during testimony in front of a newly established FDA Risk Communication Advisory Committee. Learn more »
Safety Alerts
For more information about Safety Alerts, please visit the FDA Website.
2008
Possible Malfunction of Implantable Medical Devices by CT Scanning (7/14/2008) — On July 14, 2008 the Food & Drug Administration (FDA) issued notice that the Agency has received a small number of reports of adverse events in which computed tomography (CT) scans may have interfered with pacemakers, ICDs, among other electronic medical devices. Learn more »
2007
Daylight Savings Time Change Three Weeks Earlier— Impact on Implanted Medical Devices (03/10/2007) — The Congressional passage of the Energy Policy Act of 2005 requires the start of Daylight Saving Time to begin on March 11, 2007, rather than April 1, 2007. Learn more about the impact of this time change on implanted medical devices.
2006
Magnets May Pose Serious Risks for Patients with Pacemakers and ICDs (11/30/2006) — Magnets may interfere with the operation of pacemakers and implantable cardioverter defibrillators (ICDs), according to a study published in the December 2006 edition of HeartRhythm. Learn more »
Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands (01/01/2006) — FDA has issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the 460-470 MHz frequency bands after December 31, 2005. This interference could compromise patient safety. Learn more »
2002
FDA Public Health Notification: Diathermy Interactions With Implanted Leads and Implanted Systems With Leads (2002) — FDA has received reports in which patients with implanted deep brain stimulators (DBS) died after receiving diathermy therapy. The FDA issued a notification to the doctors about this issue. View the notification (PDF, 92K)
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Biotronik
Performance Report: Visit the Biotronik’s website. Request a hardcopy from their Technical Hotline at 1 (800) 284-6689. The Society recommends that this information be provide online information.
Product Advisory Letter: No product safety alert website could be found at this time. The Society recommends that the manufacturer provide online information.
Free Pre-paid Explant Return Boxes: Biotronik requires their industry representatives handle all explant returns including mailing the explants back to the manufacturer. Call 1 (800) 284-6689 for further information.
No communication from the Society about a safety alert at this time.
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Boston Scientific (formally known as Guidant)
Performance Report: Visit the Boston Scientific's website.
Product Advisory Letter: Visit the Boston Scientific Advisory 's website to get the latest information.
Free Pre-paid Explant Return Boxes: Need to order Boston Scientific Explant Return Boxes? Telephone +1 (651) 582-2698.
2006
Boston Scientific Announces Physician Communication Related to Products in Its CRM Group (07/2006) — Boston Scientific Corporation announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. Learn more »
2005
Public Health Notification: Guidant Ventak Prizm and Contak Renewal ICDs (2005) — The FDA has issued a Public Health Notification for the "Guidant VENTAK PRIZM(r) 2DR and CONTAK RENEWAL(r) and RENEWAL(r) 2 Implantable Cardioverter Defibrillators. It has been classified as a Class I recall. Learn more »
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Medtronic
Performance Report: Visit the Medtronic's website.
Product Advisory Letter: Visit theMedtronic's Advisory 's website to get the latest information.
Free Pre-paid Explant Return Boxes: Need to order Medtronic Explant Return Boxes? Telephone +1 (800) 328-2518, extension 44800 or 48644.
2007
Medtronic Suspends Sprint Fidelis Lead Distribution (11/15/2007) — Medtronic suspended distribution of its Sprint Fidelis® defibrillation leads after the death of five patients where a lead fracture may have been a contributing factor. It has been classified as a Class I recall. Learn more »
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Sorin
Performance Report: Visit Sorin’s website. Performance Report is on the right hand side.
Product Advisory Letter: Visit Sorin’s website. No specific product safety alert website could be found at this time. The Society recommends that the manufacturer provide online information.
Free Pre-paid Explant Return Boxes: Sorin requires that their industry representatives handle all explant returns including mailing devices back to the manufacturer. Contact 1 (800) 352-6466 for further information.
No communication from the Society about a safety alert at this time.
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St. Jude Medical
Performance Report: Visit St. Jude’s website. Performance Report is located in the third column
Product Advisory Letter: Visit the St. Jude's Advisory 's website to get the latest information.
Free Pre-paid Explant Return Boxes: Need to order St. Jude Explant Return Boxes? Telephone +1 (800) 681-9293.
No communication from the Society about a safety alert at this time.
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