Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, models KVDD701 and KVDD901.
Recall
- Recall Number
- Z-1519-2009
- Event Number
- 52076
- Firm
- Medtronic Inc. Cardiac Rhythm Disease Managment
- FEI Number
- 2182208
- Product Code
- NVZ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 18, 2009
- Posted
- June 11, 2009
- Terminated
- March 28, 2012
- Address
- 8200 Coral Sea St. N.E., Saint Paul, MN, 55112
Description
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, models KVDD701 and KVDD901.
One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
5550