BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1854864 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09293
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S46
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 DURING A PLANNED DEVICE CHANGE OUT, IT WAS DISCOVERED THAT THERE WAS AN ATRIAL LEAD CONDUCTOR WIRE FRACTURE AND INSULATION BREAK. THE LEAD WAS CAPPED AND A NEW LEAD IMPLANTED. IT WAS ALSO REPORTED THAT THE PHYSICIAN PROPHYLACTICALLY IMPLANTED A NEW RIGHT VENTRICULAR PACE/SENSE LEAD. THERE WERE NO PATIENT COMPLICATIONS 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. 5594 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R 7276 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD