BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2930094 · Received January 25, 2013

    Report

    Report Number
    2124215-2013-01953
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 A TELEMETRY UNIT SHOWED INDICATION THAT THE NEWLY IMPLANTED RIGHT ATRIAL (RA) LEAD HAD DISLODGED. IT WAS OBSERVED THAT ATRIAL PACING WAS INTERMITTENTLY CAPTURING THE VENTRICLE. THERE WAS INTERMITTENT LOSS OF CAPTURE ON THE RA LEAD. NOISE WAS NOT OBSERVED ON THE ATRIAL LEAD, EXCEPT WHEN THE VENTRICLE DEPOLARIZED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED TO VVI FROM DDD. AN X-RAY WAS PERFORMED AND DISLODGEMENT WAS NOT OBSERVED; THE LEAD WAS STILL ATTACHED TO THE MYOCARDIUM. HOWEVER, MICRODISLODGEMENT COULD NOT BE RULED OUT. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35690 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R E110| 0138| 4480| 4087