It was reported that a low voltage alert, code 1003, was recorded on this cardiac resynchronization therapy pacemaker (crt-p) pre-implant.
If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.
This appears to be the case with this device.
Device voltage recovered when device was warmed.
Device was not implanted.
No patient involvement.
At this time, the product has not been returned.
If the product is returned, analysis will be performed and this report would be updated at that time.
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