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5392 DUAL CHAMBER EXTERNAL PACEMAKER (2015-03-17)
- Starting date:
- March 17, 2015
- Posting date:
- April 2, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Identification number:
- RA-52787
Recalled Products
5392 DUAL CHAMBER EXTERNAL PACEMAKER
Reason
Medtronic Model 5392 EPGS could experience a performance issue when used with specific AA-sized (LR6) batteries. Medtronic has received six (6) reports (out of approximately 6,000 model 5392 EPGS distributed globally) where the negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connection with the battery drawer electrical contact. This issue could prevent the EPG from powering on or cause the EPG to abruptly lose primary battery power, potentially stopping delivery of pacing therapy. There have been no reports of patient harm as a result of any occurrence of this issue.
Affected products
5392 DUAL CHAMBER EXTERNAL PACEMAKER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5392
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
Minnesota
UNITED STATES