Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.

FDA device recall Z-0665-2009 · posted 2009-01-28 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Managment

Reason for recall

Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm

Action taken

A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.

Root cause

Process design

Status

Terminated

Product code

LWS

Quantity affected

419

Distribution

No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.

Date initiated

2008-07-25

Date posted

2009-01-28

Date terminated

2011-05-07

Location

Mounds View, MN