Model Number 3788 |
Device Problems
Nonstandard Device (1420); Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2015 |
Event Type
Injury
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Event Description
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It was reported the patient (australia) experienced difficulty recharging the ipg.The charging system is unable to locate the ipg.Per the patient, the ipg was last charged about a month ago and the patient lost stimulation about a week ago.Follow-up identified the ipg appeared to have partially flipped.Surgical intervention will take place to address the issue.
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Event Description
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It was reported surgical intervention was undertaken to explant and replace the patient's ipg.Effective stimulation was recaptured postoperative.
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Manufacturer Narrative
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Correction numbers: 1627487-07262012-002-r, 1627487-12192011-003-r.This ipg serial number was included in field advisories.(b)(4).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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Results: the complaint for 'no communication' was confirmed.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg passed all tests.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.
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Search Alerts/Recalls
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