BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1861534 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10040
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 A NEW ATRIAL LEAD WAS IMPLANTED IN (B)(6) 2010 AND THAT THE LEAD THRESHOLD HAD CONTINUED TO INCREASE SINCE IMPLANT. DUE TO THE PATIENT'S AGE AND HEALTH, THE PHYSICIAN DID NOT WANT THE PATIENT TO UNDERGO LEAD REVISION. THE PHYSICIAN WILL LEAVE ATRIAL LEAD PROGRAMMED HIGH. THE HEALTH PROFESSIONAL REQUESTED A DEVICE LONGEVITY ESTIMATE FOR THE DEVICE AT THE PATIENT'S PROGRAMMED PACING PARAMETERS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other 5092 IMPLANTABLE PACING LEAD| SEDR IMPLANTABLE PULSE GENERATOR