BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2964912 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02370
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FURTHER REPORTED THAT THE PATIENT WENT TO THEIR PHYSICIAN'S OFFICE AND WAS HYSTERICAL AND COMPLAINING OF BEING "WIPED OUT." THE DEVICE WAS CHECKED AND EVERYTHING CHECKED OUT FINE. FOLLOW-UP WAS CONDUCTED FOR ADDITIONAL INFORMATION. FROM FOLLOW-UP IT WAS ALSO REPORTED THAT THE PATIENT'S SYMPTOMS ARE NOT DEVICE RELATED AND THE SYSTEM IS FUNCTIONING NORMALLY. THE PHYSICIAN DID TRY TO PROGRAM THE DEVICE FOR OPTIMIZATION FOR THE PATIENT BUT WAS REPROGRAMMED BACK THE VERY NEXT DAY BECAUSE THE PATIENT DID NOT LIKE THE SETTING. THE DEVICE REMAINS IN USE AS THERE ARE NO ALLEGATIONS AGAINST THE PERFORMANCE OF THE SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT THEY HAVE SYMPTOMS OF GETTING REALLY SICK, MUSCLES QUIVER, NOT UNABLE TO WALK DISTANCES, AND GOES TO THE BATHROOM A LOT AS THE PACEMAKER "LIGHTS UP MY KIDNEYS" AND YET THEIR DEVICE IS NOT RECORDING ANYTHING. PATIENT HAS HAD DEVICE CHECKS WHERE THE PACEMAKER WAS NOT SHOWING A PROBLEM BUT THE PHYSICIAN AND MEDTRONIC FIELD REP STATED THAT THEY COULD SEE THAT THERE IS SOMETHING WRONG WITH THE PATIENT, BUT THE MONITOR IS NOT SHOWING ANYTHING. THE PATIENT IS CONCERNED THAT THEIR PACEMAKER IS NOT WORKING CORRECTLY. 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
    67474 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 5068 X2 IMPLANTABLE PACING LEAD