BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3041089 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00940
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE IMPLANT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH DEFIBRILLATION THRESHOLDS (DFTS). THE PATIENT HAD TO BE EXTERNALLY RESCUED. THE POCKET WAS RE-OPENED WHERE IT WAS DISCOVERED THAT THE TERMINAL PINS HAD BEEN REVERSED IN THE HEADER. THE TERMINAL PINS WERE PLACED IN THE CORRECT PORTS WITH SUBSEQUENT SUCCESSFUL DFT TESTING. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142945 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R 4037| 1861| 0147| T165