Model Number 3186 |
Device Problems
Fracture (1260); High impedance (1291); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/24/2015 |
Event Type
Injury
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Manufacturer Narrative
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(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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Event Description
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Device 1 of 2: reference mfr.Report#: 1627487-2015-05558.It was reported the patient (sweden) was unable to be reprogrammed due to high impedance.As a result, the patient underwent surgical intervention.During the procedure, the anchor was found to be fractured.The patient's lead was also fractured at the location of the anchor.In turn, the patient's lead was explanted and replaced.The patient's anchor was also explanted.Surgical intervention resolved the patient's issue.
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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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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05558.Follow-up revealed the patient's issue that was initially reported may have resulted from a fall the patient had experienced.
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05558.
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Search Alerts/Recalls
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