BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2964929 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02125
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 16, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEIR HEART RATE IS GOING FAST, THE DEVICE "IS WAKING ME UP IN THE MIDDLE OF THE NIGHT AND CAN FEEL THEIR BODY THROBBING". THERE IS ALSO A LOT OF PAIN AROUND THE DEVICE AREA. FOLLOW UP WAS ATTEMPTED TO SEE IF THE COMPLAINTS WERE DEVICE RELATED, BUT PATIENT HAS NOT BEEN SEEN BY THEIR PHYSICIAN REGARDING THESE SYMPTOMS. THE DEVICE IS STILL 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
    68117 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR 5076 X 2 IMPLANTABLE PACING LEADS