BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173242 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11445
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED WITH A SECTION OF THE OUTER COILS STRETCHED. ALL THE INSULATIONS AND COIL MATERIALS WERE CONSISTENT WITH THIS MODEL LEAD. NO INDICATIONS OF MELTING WERE NOTED ON THE OUTER INSULATION AT APPROXIMATELY 525 MM (DISTAL END OF THE RETURNED PROXIMAL SEGMENT). HOWEVER, IT COULD NOT BE DETERMINED WITH THE OUTER INSULATION WAS CUT OR TORN AT THIS LOCATION. BOTH THE INNER AND OUTER COILS WERE FRACTURED AT THE DISTAL END OF THE RETURNED PROXIMAL SEGMENT. TWO OF THE INNER COIL WIRES SHOWED SOME EVIDENCE OF FATIGUE, WHILE THE OTHER TWO WERE EXTENSIVELY DAMAGED OBSCURING THE FAILURE MODE. THE DISTAL END OF THE THREE OUTER COILS SHOWED EVIDENCE OF TORSIONAL FATIGUE, WHILE THE SINGLE WIRE AT APPROXIMATELY 550 MM ON THE OUTER COIL WAS CUT.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS CAUSING POCKET STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. AN INSULATION BREAK, WITH AN EXPOSED CONDUCTOR WIRE, WAS SEEN. UPON ATTEMPTING TO EXTRACT THE LEAD, THE LEAD FRACTURED. THE PROXIMAL END OF THE LEAD WAS EXPLANTED AND THE DISTAL END REMAINED IN THE PATIENT. THE PATIENT WAS THEN BROUGHT BACK AT A LATER TIME AND THE DISTAL END OF THE LEAD WAS REMOVED VIA A LASER PROCEDURE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R 0184| H217| 4135| 4555