BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1863112 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05013
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 DEVICE 'STICKS OUT' OR IS 'BULGING OUT'. SHE SAID THEY HAD TO MOVE THE PACEMAKER BELOW THE MUSCLE AND IT HAS 'MOVED 2 INCHES' SINCE THE SURGERY. SHE ALSO SAID SHE WAS CONCERNED THAT THE LEADS WERE 'CROOKED' AND THAT YOU CAN 'SEE THEM THROUGH THE SKIN'. SHE SAID DOCTORS HAVE TOLD HER THE DEVICE IS FUNCTIONING 'NORMAL'. THE LEADS AND DEVICE REMAIN 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 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention