BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3021416 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04240
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 11, 2013
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 889-28, LOT# VA04D8P, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3889-28, LOT# VA04D8P, IMPLANTED: (B)6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT STIMULATION IN THE WRONG AREA AND HAD A LACK OF THERAPEUTIC EFFECT. IT WAS ADDED THAT THE PATIENT ONLY FELT STIMULATION IN HER LEFT LEG. IT WAS STATED THAT THE PATIENT FELT A "CHARLEY-HORSE" AND IT PROMPTED HER LEG TO OCCASIONALLY "GIVE OUT" ON HER. IT WAS NOTED THAT THE PATIENT MET WITH HER DOCTOR ON (B)(6) 2012 TO MAKE ADJUSTMENTS. IT WAS ADDED THAT THE PATIENT STATES SHE HASN'T FELT THE STIMULATION SINCE THEN, EXCEPT WHEN SHE RECENTLY TRIED TO TURN HER STIMULATION UP TO 4.0 VOLTS. IT WAS STATED THAT PATIENT HAD REPROGRAMMING DONE ON (B)(6) 2013 AND THE PATIENT'S STIMULATION DECREASED BECAUSE OF THIS. IT WAS STATED THAT AFTER NUMEROUS ATTEMPTS AT REPROGRAMMING, IT WAS DECIDED TO REVISE THE LEAD AND IMPLANT A NEW ONE ON THE CONTRALATERAL SIDE DUE TO PAIN DOWN THE LEG AND THE LOSS OF THERAPEUTIC EFFECT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123081 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention