BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7239699 · Received February 3, 2018

    Report

    Report Number
    3004209178-2018-02023
    Event Type
    Malfunction
    Date Received
    February 3, 2018
    Date of Event
    January 17, 2018
    Report Date
    February 3, 2018
    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
    MI, 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 CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT RECENTLY HAD A "KST" PROCEDURE DONE AT THE CHIROPRACTORS OFFICE THAT INVOLVED TAPPING THE SPINE AND ARM. THEY REPORTED THAT HAD BEEN GETTING THIS PROCEDURE DONE FOR YEARS BUT THE CHIROPRACTOR FORGOT AND "TAPPED" RIGHT OVER THE INTERSTIM DEVICE AND PATIENT REALLY HURT FROM IT. THEY FURTHER REPORTED THAT (B)(6) THEY EXPERIENCED A RETURN OF SYMPTOMS WITH BOTH BLADDER SYMPTOMS AND BOWEL INCONTINENCE BUT NOTED THE "SYMPTOMS WEREN'T TOO BAD BUT ARE STARTING". PATIENT SAID THAT THEY NEEDED TO RUSH TO THE BATHROOM. THEY ALSO MENTIONED THAT THE INS WAS IMPLANTED FOR BLADDER AND BOWEL SYMPTOMS BUT ALSO HAPPENED TO HELP WITH PAIN IN THEIR HIP AND LEG AND NOW AFTER THE KST PROCEDURE, THEY ALSO EXPERIENCED A RETURN OF THIS PAIN. PATIENT DID STATED THE MACHINE IS STILL WORKING AND THEY CAN STILL CHANGE PROGRAMS. MOREOVER, PATIENT BELIEVED THEY WERE DUE FOR A NEW INS BATTERY BECAUSE THEIR DOCTOR WAS SURPRISED THE INS HAD LASTED THIS LONG AND ALSO NOTED THEY KEEP THE STIM SETTINGS LOW AND DOESN'T CHANGE THEM. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83096 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR