BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6472015 · Received April 7, 2017

    Report

    Report Number
    3004209178-2017-07816
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    August 14, 2016
    Report Date
    April 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION A ND GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING BACK ISSUES AND BACK PAIN AND NEEDED TO SEE A CHIROPRACTOR. THE PATIENT HAD A LOT OF PAIN IN THEIR BACK AND SHOULDERS THE LAST 6-7 MONTHS AND DID NOT KNOW IF IT WAS DEVICE RELATED OR DUE TO THEIR JOB OR SOMETHING ELSE. THE PAIN WAS RIGHT WHERE THEIR BRA GOES ACROSS THEIR BRA BUT A LITTLE BIT LOWER DOWN AND IN AN AREA THAT TAKES THEIR BREATH AWAY BECAUSE THEY WERE IN SO MUCH PAIN ALL THE TIME. THE PATIENT STATED THEY RECENTLY STARTED GOING TO A CHIROPRACTOR AND HAD BEEN JUST ONCE. THE CHIROPRACTOR KNEW WHERE THE STIMULATOR WAS LOCATED AND DID AN ADJUSTMENT WHERE THEY ¿REALLY MOVED HER HIPS¿ AND THE PATIENT KEPT GETTING THESE LITTLE ¿ZINGS¿. THE PATIENT FELT THE ZINGS RIGHT AFTER THE ADJUSTMENT WAS DONE BUT ALSO HAD SOME OF THE ¿ZINGS¿ BEFORE THE ADJUSTMENT SO IT WASN¿T ¿TO THE ¿N¿TH EXTREME¿. IT WAS NOTED THE ADJUSTMENT DID SEEM TO HELP WITH THE PAIN BUT THE PATIENT WAS SCARED THE CHIROPRACTOR WAS GOING TO SHIFT THEIR WIRES WITH THE ADJUSTMENTS BECAUSE THEY HAD NOT HAD THEIR DEVICE A YEAR YET. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) REGARDING THE SYMPTOMS, AND ADVISED THAT THEY HAD THE OPTION TO TURN OFF THE DEVICE TO SEE IF THE PAIN ISSUE RESOLVED ONCE THE DEVICE WAS OFF. ¿MANUAL ADJUSTMENTS BY CHIROPRACTOR¿ AND ¿DENTAL WORK¿ WERE REVIEWED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255533 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR