Model Number 0144 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438)
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Patient Problems
Perforation of Vessels (2135); Vascular Dissection (3160); No Code Available (3191)
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Event Date 06/25/2010 |
Event Type
Injury
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Manufacturer Narrative
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No additional information is available.If additional information becomes available the report will be updated at that time.(b)(4).
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Event Description
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It was reported that there was oversensing of noise on the right ventricular (rv) lead and implantable cardioverter defibrillator (icd).The patient had an underlying rhythm thus no asystole occurred.Sensitivity was reprogrammed.The patient was referred to an electrophysiologist to determine further course of action.It was noted that just under five years later a revision procedure was performed and the lea was taken out of service.Over four and a half years later it was reported that this revision procedure occurred due to continued oversensing, including.T wave oversensing.It was further reported that when the physician attempted to remove the leads, he perforated and tore the svc.Emergent open heart surgery occurred and the lead was surgically abandoned.The lead was later explanted and once the patient healed from the open heart surgery an subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.
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Event Description
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This report is being filed to correct the device evaluated by manufacturer, method codes and additional mfr narrative fields that were inadvertently incorrect on the last report.
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Manufacturer Narrative
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The lead had previously been returned and analyzed.Upon receipt at our post market quality assurance laboratory visual inspection noted it was returned in two segments.The terminal segment was severed at 18 cm from the terminal pin.The second segment was the middle segment equaling 19 c in length.It was noted that the rate sense negative coils were missing.Calcium was noted on the distal shocking coil.The returned portions of the lead passed electrical testing.The field allegations of noise and oversensing were not able to be confirmed through testing of the returned portions of the lead.Patient code 3191 captures the additional intervention.This report is being filed to correct the h3 device evaluated by manufacturer, h6 method codes and h10 additional mfr narrative fields that were inadvertently incorrect on the last report.
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Search Alerts/Recalls
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