Model Number 7121/65 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930)
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Event Date 03/28/2023 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 2017865-2023-18456, related manufacturer reference number: 2017865-2023-18458, related manufacturer reference number: 2017865-2023-18459.It was reported that the patient presented in the emergency room due to sepsis.It was noted that there was presence of pus drainage coming from the implantable cardioverter defibrillator (icd) wound incision and wound dehiscence was observed which exposed the icd, right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead.Pocket revision was performed on (b)(6) 2023 due to infection and wound dehiscence.The patient's condition was stable.
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Event Description
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New information received notes that the patient presented to the emergency room again due to the presence of pus coming from the implantable cardioverter defibrillator (icd) wound incision site and wound dehiscence was observed which exposed the icd, right ventricular (rv) lead, right atrial (ra) lead and left ventricular (lv) lead.The entire icd system was explanted on (b)(6) 2023 due to recurrence infection and wound dehiscence.The patient's condition was stable.
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Manufacturer Narrative
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A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The reported event was infection and wound dehiscence.As received, a partial lead (distal portion) was returned in one piece measuring 49.5cm/47.0cm/46.5cm (inner coil/ptfe liner and cables/lead body).Electrical testing did not find any indication of conductor fractures or internal shorts.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found external insulation abrasion on the lead consistent with friction to the device can breaching the optim sheath only at 43.0 cm to 44.2 cm from the proximal region of the lead.The silicone tubing was not abraded.
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Search Alerts/Recalls
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