Model Number 3186 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 12/08/2014 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2014-03795.It was reported the patient is to undergo surgical intervention regarding his scs leads.No additional information is available at this time.
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Event Description
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Device 1 of 2 reference mfr.Report: 1627487-2014-03795.
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Event Description
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Device 1 of 2.Reference mfr.Report: 1627487-2014-03795.
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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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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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Explant date: the explant and replacement(different model)/explant date was inadvertently omitted from the initial report.The explant date has been added.Results: the complaint of 'ineffective stimulation" was confirmed.As received, octrode lead designated sn (b)(4) had a kink where all of the wires were broken in the lead body along with a cam impression.The fracture was consistent with repetitive overstress the lead was subjected to near the distal end of the swift-lock anchor while in vivo.The swift-lock anchors were returned with anomalies consistent with explant damage.The locking mechanism of both functioned as intended.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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