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Terminated

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 Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands.

FDA Recall Z-0999-2007 · Posted 2007-07-07

Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeNVZ
Date Initiated2007-02-05
Date Terminated2008-10-16
Product Quantity4,294

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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