BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3422206 · Received October 22, 2013

    Report

    Report Number
    3004209178-2013-19455
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Report Date
    October 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# V850492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AND STILL HAD PROBLEMS AFTER HAVING LASER TREATMENT FOR KIDNEY STONES. THE PATIENT WANTED TO TURN STIMULATION OFF TO SEE IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CAUSING HER PAIN. THE PATIENT HAD BEEN GOING BACK AND FORTH TO THE HOSPITAL SINCE LAST TUESDAY. THE LASER PROCEDURE WAS PERFORMED ON (B)(6) 2013 AND THE PATIENT STILL HAD SEVERE PAIN. IT WAS STATED THAT THE PATIENT WAS NORMALLY SET AT 2.7 VOLTS (3.0 VOLTS WAS NORMALLY THE HIGHEST THE PATIENT COULD GO) AND NOW THE PATIENT WAS AT 4.6 VOLTS AND COULD STILL NOT FEEL STIMULATION. THE PATIENT CONFIRMED THAT THE INS WAS ON THE SAME PROGRAM AS PRIOR TO THE PROCEDURE, PROGRAM 1. IT WAS ALSO MENTIONED THAT THE PATIENT DID NOT TURN OFF THE INS PRIOR TO SURGERY. THE PATIENT WAS PREVIOUSLY TOLD WHEN SHE HAD ¿BLADDER STUFF¿ DONE THAT SHE DID NOT HAVE TO TURN THERAPY OFF. THE PATIENT WAS CURRENTLY ON PAIN MEDICATION DUE TO THE KIDNEY STONES AND WAS INSTRUCTED THAT THIS MIGHT HAVE AN EFFECT ON THERAPY. THE PATIENT WAS THEN INSTRUCTED HOW TO TURN STIMULATION OFF AND CONFIRMED STIMULATION WAS OFF AND DOWN TO 0.0 VOLTS. IT WAS ADDED THAT THE PATIENT HAD HISTORY OF KIDNEY STONES. PLEASE REFER TO MFG. REPORT # 3004209178-2013-19451, AS THE PATIENT HAD AN EVENT AT THE BEGINNING OF (B)(6) 2013 WHEN THE PROGRAMMING WAS LOST (SAME INS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541690 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR