BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2911252 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16488
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AND THE ORIGINAL RV WAS DISCARDED, 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 THE POST-OPERATIVE DEVICE CHECK FOLLOWING PACEMAKER IMPLANT, THE RIGHT VENTRICULAR (RV) THRESHOLD MEASUREMENT OBSERVED WAS BETWEEN 3.0-4.0V. CURRENT PROGRAMMING POST-IMPLANT INDICATED AUTOCAPTURE ON AND AN OUTPUT OF 3.5V SINCE IMPLANT. THE RV LEAD APPEARED TO BE MOSTLY CAPTURING THE CARDIAC TISSUE; HOWEVER, 3 PAUSES WERE NOTED ON THE MONITOR BY THE NURSES. THE PATIENT REMAINED ASYMPTOMATIC WITH THE INTERMITTENT CAPTURE. THE RV OUTPUT WAS REPROGRAMMED TO 7.5V TO ENSURE CAPTURE WHILE THE PATIENT WAS RESCHEDULED FOR A LEAD REVISION LATER THAT DAY. AT THE REVISION PROCEDURE, THE ORIGINAL RV LEAD WAS REMOVED AND DISCARDED. A NEW RV LEAD OF SAME MODEL TYPE WAS SUCCESSFULLY IMPLANTED AND FUNCTIONING APPROPRIATELY. AUTOCAPTURE WAS AGAIN PROGRAMMED ON. THE PATIENT WAS LATER DISCHARGED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17822 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R