BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2802043 · Received October 23, 2012

    Report

    Report Number
    2649622-2012-15609
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 BY THE PHYSICIAN THAT REVIEW OF THE PATIENT'S HOLTER MONITOR STRIPS NOTED PERIODIC LOSS OF TRACKING AND THE PHYSICIAN QUESTIONED THE NUMBER OF PREMATURE VENTRICULAR CONTRACTIONS IN A PACEMAKER DEPENDENT PATIENT. FOLLOW UP ASSESSMENT OF THE PATIENT WAS UNABLE TO REPRODUCE THE EVENT DURING PROACTIVE ARM MOVEMENTS BUT LOSS OF CAPTURE AND VENTRICULAR OVERSENSING WERE SEEN DURING A TREADMILL TEST. THE LEAD WAS REPROGRAMMED TO MAKE THE LEAD LESS SENSITIVE. 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention ADDRS1 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD