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Model Number 5392 |
Device Problems
Use of Device Problem (1670); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: analysis was unable to confirm the customer comment that the external pulse generator (epg) did not read properly.The lower case, upper case and the hanger assembly were broken.All encoder nuts were loose.The hanger screw was contaminated.All found defective parts were replaced and all other identified issues were resolved.The epg then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the external pulse generator (epg) had a malfunction and was not reading properly.There was no patient involvement.
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Search Alerts/Recalls
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