BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130504 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10181
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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 PATIENT WAS EXPERIENCING "THE FLU AND/OR A HEART ATTACK", "SHORTNESS OF BREATH, TIRED[NESS], COUGHING, AND SICK AS A DOG" AND THE CLINICIAN AT THE PHYSICIAN'S OFFICE "DID NOT PAY ATTENTION." THE PATIENT REPORTS THAT "[THE MANUFACTURER OF THE DEVICE AND LEADS] AND THE DOCTOR IS AT FAULT." THE PATIENT ALSO REPORTED THE DEVICE "BATTERY IS LOW" AND THERE SHOULD HAVE BEEN BETTER EXPLANATION OF POSSIBLE SYMPTOMS. ADDITIONALLY, THE PATIENT IS DISSATISFIED BECAUSE THE "WIRES STICK UP AND [THE PATIENT] CANNOT EVEN WEAR A BATHING SUIT", THE MANUFACTURER "DID NOT DO THEIR TEACHING" AND THE PATIENT "HATES [THE] DEVICE." IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED FOR NORMAL DEVICE DEPLETION AND THE PHYSICIAN IMPLANTED A SINGLE CHAMBER DEVICE DUE TO PERMANENT ATRIAL FIBRILLATION. THE LEADS DID NOT APPEAR TO BE STICKING UP. THE ATRIAL LEAD WAS CAPPED AND THE VENTRICULAR 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R