BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4243756 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21332
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V498347, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE NEUROSTIMULATOR HAD MOVED, AND SHE THOUGHT IT STARTED TO MOVE WITHIN THE LAST YEAR HOWEVER SHE NOTICED IT SOME MONTHS BACK. THE PATIENT INDICATED THAT IT WAS NOW DIRECTLY ON HER BACKBONE. IT WAS NOTED THAT THE PATIENT RECEIVED REGULAR BONE DENSITY SCREENING DUE TO BONE CONDITION AND WAS TOLD BY THE TECHNICIAN THAT SHE WAS UNABLE TO SCAN LOWER BACK AS DEVICE WAS RIGHT ON PATIENT¿S TAILBONE. IT WAS INDICATED THAT PATIENT HAD HAD SEVERAL FALLS, LOSES HER BALANCE AND HAD INJURED HER FACE AS A RESULT. THE PATIENT MENTIONED THAT THE STIMULATION WAS IRRITATING TO THE LIPS OF HER VAGINA, SHE THEN TURNED STIMULATION OFF AND IT HAD BEEN OFF FOR AT LEAST ONE YEAR. THE PATIENT WANTED THE DEVICE/SYSTEM REMOVED. THE PATIENT REPORTED THAT SHE NEVER HAD THERAPEUTIC EFFECT. THE PATIENT HAD HAD SOME REPROGRAMMING SESSIONS BUT HOWEVER THAT DID NOT HELP. THE PATIENT ALSO MENTIONED THAT THE IMPLANTING HCP TOLD HER THAT HE COULDN'T HOLD OFF THE WIRE ON ONE SIDE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726868 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR