BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3213265 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11489
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD JUST SEEN THE HEALTHCARE PROVIDER (HCP) WHO HAD TO REPROGRAM THE DEVICE BECAUSE THE DEVICE WAS TURNED OFF. IT WAS INDICATED THAT IT WAS THE FIRST TIME THIS HAD HAPPENED. IT WAS ALSO REPORTED THAT THE HCP HAD ADVISED PATIENT THAT PATIENT MIGHT HAVE COME INTO CONTACT WITH AN ELECTROMAGNETIC FIELD. IT WAS INDICATED THAT THE ISSUE SOUNDED LIKE A POWER ON RESET (POR). IT WAS STATED THAT THERE WAS A POWER SURGE AT THE PATIENT¿S HOME THAT HAD MADE A LARGE "POUF" SOUND AND HAD NO POWER FOR A COUPLE OF HOURS AFTER THAT. IT WAS LATER REPORTED THAT PATIENT HEALTHCARE PROVIDER TOLD PATIENT THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS 'DEPROGRAMMED' AND NEEDED TO BE REPROGRAMMED. IT WAS ADDED THAT PATIENT WAS WORRIED BECAUSE HCP MENTIONED COMPUTERS OR MICROWAVES INTERFERENCE. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314242 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1