Company:St Jude Medical CRMD.
Date of Enforcement Report 7/13/2011
Class ll:
PRODUCT
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia. Recall # Z-2733-2011
REASON
The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM after the device is interrogated by a Mertin programmer with 10.1.1.2 software.
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter on March 25, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide and Germany
