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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