BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 2936186 · Received January 30, 2013

    Report

    Report Number
    3007566237-2013-00323
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT A PATIENT SAW A POWER-ON-RESET (POR) MESSAGE ON THEIR PROGRAMMER. THERE WAS LIMITED INFORMATION ABOUT THE EVENT. THE REPORTED DID NOT KNOW IF THE PATIENT HAD BEEN EXPOSED TO ANY ELECTROMAGNETIC INTERFERENCE. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT ONLY NEEDED HIS BATTERY TURNED BACK ON USING THE CLINICIAN PROGRAMMER. IT WAS STATED THAT THE PATIENT WAS 'DOING GREAT.' NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41115 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1