BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792669 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07054
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DURING THE PROCEDURE FOR PULSE GENERATOR REPLACEMENT FOR NORMAL BATTERY DEPLETION THAT THE LEAD HAD HIGH THRESHOLDS. THE LEAD WAS CAPPED AND SURGICALLY ABANDONED AND ANOTHER LEAD WAS IMPLANTED TO REPLACE IT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 71 YR Required Intervention 5076-52 IMPLANTABLE PACING LEAD| 5076-58 IMPLANTABLE PACING LEAD