BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1803298 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08816
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    April 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWED INCREASED THRESHOLDS AND APPARENT FRACTURE. THE LEAD WAS REPOSITIONED, AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT FURTHER REPORTED THAT DURING A ROUTINE CHECKUP, THE DOCTOR AND TECHNICIAN DISCOVERED AN UNEXPECTED LEVEL OF BATTERY STATUS AND TOLD HER IT WOULD NOT LAST MORE THAN TWO OR THREE YEARS. PATIENT SAID SHE WAS TOLD THAT SHE NEEDED TO HAVE THIS UNIT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 5076 IMPLANTABLE PACING LEAD