Model Number 3788 |
Device Problems
Nonstandard Device (1420); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Recall: 1627487-07262012-002-r, 1627487-12192011-003-r.This ipg serial number was included in field advisories.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).
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Event Description
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It was reported the patient turned stimulation off over a month ago (event date is unknown).Reportedly, the external devices will not longer locate the ipg and the patient programmer displays an error message.Subsequently, the patient programmer was replaced to no avail.The ipg is inoperable.Surgical intervention may be undertaken as the next course of action to address the issue.
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Event Description
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Follow-up identified surgical intervention was undertaken during which time the ipg was explanted and replaced.Therapy was restored postoperatively.
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Search Alerts/Recalls
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