Model Number 3608 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/04/2014 |
Event Type
Injury
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Event Description
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It was reported the patient's (finland) ipg displayed a low battery warning due to possible premature battery depletion, however, the patient did not lose stimulation.Surgical intervention was undertaken and the ipg was explanted and replaced.The patient reported effective stimulation coverage postoperative.
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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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Evaluation codes results: a visual inspection of the ipg did not reveal any discrepancies.Communication with the ipg as received was normal.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.The pulse load testing of the ipg battery confirmed the ipg low battery indication noted in the field was due to ipg battery passivation.The ipg battery was more prone to passivation at the settings used during the device implant period.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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