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Health product recall

SICD System Pulse Generators (2017-07-04)

Starting date:
July 7, 2017
Posting date:
July 17, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-63996

Affected Products

A. SICD System - Sq-Rx Pulse Generator
B. Emblem S-ICD Pulse Generator
C. Emblem MRI S-ICD PG

Reason

Observations indicate that this device delivered an atypical amount of energy likely contributing to patient death. The most likely cause was a transient corruption of the S-ICD operating state or device memory due to a single event upset (SEU). SEU's are known to affect memory in electronic devices and high reliability devices (pacemakers or defibrillators) include mechanisms to deal with this issue to reduce the occurrence of potentially harmful malfunctions.

Affected products

A. SICD System - Sq-Rx Pulse Generator

Lot or serial number

Not Applicable

Model or catalog number

1010

Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES

B. Emblem S-ICD Pulse Generator

Lot or serial number

Not Applicable

Model or catalog number

A209

Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES

C. Emblem MRI S-ICD PG

Lot or serial number

Not Applicable

Model or catalog number

A219

Companies
Manufacturer
Cardiac Pacemakers Incorporated
4100 Hamline Avenue North
St. Paul
55112
UNITED STATES