Model Number 1192 |
Device Problem
Fracture (1260)
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Patient Problems
Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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"date of event¿ is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference numbers: 3006705815-2020-32703, 3006705815-2020-32704, 1627487-2020-49025, 1627487-2020-49026.It was reported that patient fell and experienced uncomfortable therapy in the wrong location.Diagnostics showed low impedance on multiple contacts of the leads.Additional information was received that patient also experienced shocking in ipg pocket.Surgery occurred to address the issue.During the surgery, one anchor and one lead were found to be broken.The system was replaced to address the issue.It is unknown which anchor and lead were broken so all suspected devices are being reported.
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Manufacturer Narrative
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The reported uncomfortable stimulation and impedance issues were not confirmed.The anchor was returned broken in 2 pieces.As this damage was observed before it was explanted, the damage is consistent with the anchor being subjected to stress, while in vivo.The source of the stress could have been the fall the patient experienced, but this could not be conclusively determined.Despite the damage, the locking mechanism of the anchor functioned as intended.
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Search Alerts/Recalls
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