BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1854768 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04422
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    May 20, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 BY THE PATIENT THAT HER PACEMAKER IS IN HER ABDOMEN AND "FLIPS" WHEN SHE BENDS OR THAT IT "GETS IN THE WAY" WHEN SHE WEARS CERTAIN CLOTHES. SHE ALSO REPORTED THAT "SHE FEELS A BUMPING OR KNOCKING FROM HER DEVICE 2-3 TIMES A DAY". THE PATIENT WAS REFERRED TO HER PHYSICIAN. THE DEVICE 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 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 4965 X2 IMPLANTABLE PACING LEAD