|
Model Number 5392 |
Device Problems
Mechanical Problem (1384); Use of Device Problem (1670); Connection Problem (2900)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product analysis: analysis confirmed that the atrial paced port of the external pulse generator (epg) did not work.The atrial output connector was damaged.The hanger assembly was broken.All found defective parts were replaced and all other identified issues were resolved.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the atrial port of the external pulse generator (epg) did not work and it had a broken battery tray door that would not close, causing it to be inoperable.The epg was returned for service.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|