BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE II

    MDR report key: 3211078 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08917
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LEAD IS NOT ABLE TO BE RETURNED, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. 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 THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS WERE FOUND TO BE GREATER THAN 2,500 OHMS. THE CHRONIC RV LEAD WAS TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND THE MEASUREMENT REMAINED OUT-OF-RANGE. AN X-RAY WAS PERFORMED, BUT NO LEAD FRACTURE WAS VISUALIZED. THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED WITH THE NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310937 THINLINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 430-25S-58

    Patients

    Seq Age Sex Outcome Treatment
    1