Model Number 102 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Failure to Anastomose (1028)
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Event Date 09/15/2014 |
Event Type
Injury
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Event Description
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It was initially reported that the patient had their vns explanted.After the explant, the patient picked at the incision and opened the pocket.There was nothing implanted in the patient at that time of the incision being picked open.
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Event Description
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Additional information was received that product analysis was completed on the lead.A coil break was identified in both the positive and negative lead coils.Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends.Secondary fractures were observed in at least two strands of the quadfilar coils.The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter.Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿.The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.The report issue found with the lead was reported on medwatch 1644487-2014-02836.
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Event Description
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Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014.Patient's stitches were taken out and replaced with steri-strips.The patient's chest incision was reported to be open with yellow drainage from it.Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.
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Manufacturer Narrative
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Evaluation not related to event.
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Search Alerts/Recalls
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