Model Number 3149 |
Device Problems
Bent (1059); High impedance (1291)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 05/07/2015 |
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.(b)(4).
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Event Description
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The patient was implanted with 4 quattrode leads; 2 model 3149(c2-c3) and 2 model 3156 (t8-t9).It was reported the two leads (model 3149) covering the patient's upper left extremities are auto-reducing.Reportedly, several of the lead contacts reveal high impedance readings.Further reprogramming of alternate contacts produced undesired stimulation in the left hand.Follow-up identified x-rays were taken revealed the lead had migrated and bent at an 90 degree angle near the anchor site.Surgical intervention was undertaken on (b)(6) 2015 during which time the lead was explanted and replaced with a new model.Effective therapy was achieved postoperatively.The issue is resolved.
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2016-00017.
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Event Description
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Device 1 of 2.Reference mfr report#1627487-2016-00017.Further investigation reveals it's unknown which lead returned.
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Search Alerts/Recalls
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