BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY SPIRAL LVA SINGLE ELECTRODE IS-1 PASSIVE 90CM

    MDR report key: 1704350 · Received May 21, 2010

    Report

    Report Number
    2124215-2010-10558
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT A 903MM PORTION OF LEAD WAS RETURNED WITH CONDUCTOR COILS EXTENDING TO 973MM AND 980MM. THE LEAD TIP WAS NOT RETURNED. THE SPIRAL HAS BEEN STRAIGHTENED OUT AND THE INSULATION HAS BEEN TORN AROUND THE CIRCUMFERENCE 903MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS ARE EXTREMELY STRETCHED AT THE DISTAL END AND HAVE BEEN PULLED TO THE POINT OF FRACTURE. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS ATTEMPTED AND NOT USED. AT INITIAL IMPLANT GOOD PLACEMENT FOR THIS LEAD COULD NOT BE FOUND. AS THE LEAD WAS BEING EXPLANTED IT WAS NOTED THAT THE LEAD TIP BROKE OFF FROM THE LEAD BODY. THIS LEAD WAS NOT USED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED IN IT'S PLACE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY SPIRAL LVA SINGLE ELECTRODE IS-1 PASSIVE 90CM IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR