Recall Z-0999-2007 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc. Cardiac Rhythm Managment
Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. C-series software is VSF11/VSF12 Version 1.0. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central
| Date | Jul 7, 2007 (initiated Feb 5, 2007) |
| Status | Terminated |
| Reason | Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate. |
| Root cause | Software design |
| Action | Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades. |
| Quantity | 4,294 |
| Distribution | within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.