Model Number S603 |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Swelling (2091); No Code Available (3191); Swelling/ Edema (4577)
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Event Date 07/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this pacemaker was explanted and replaced after the patient felt pain and swelling around the device, there was no infection.The patent has been feeling the swelling on an off for years.It was determined that the device migrated.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Normal device operation was noted during analysis.No visual irregularities noted, and normal battery depletion was noted.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
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Event Description
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It was reported that this pacemaker was explanted and replaced after the patient felt pain and swelling around the device, there was no infection.The patent has been feeling the swelling on an off for years.It was determined that the device migrated.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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