BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8437076 · Received March 20, 2019

    Report

    Report Number
    3004209178-2019-05678
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 20, 2019
    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
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-41, LOT# V872916, IMPLANTED: (B)(6) 2012 , PRODUCT TYPE: LEAD. 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 REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED BY PATIENT THAT THEIR DEVICES WERE IMPLANT FOR GROIN PAIN. PATIENT SAID THEY HAD A FEELING THE WHOLE SYSTEM WAS DEAD OR THAT THE LEAD HAS GONE BAD ON AT LEAST ONE SIDE SINCE AROUND (B)(6) 2019. THEY SAID THE DEVICE HAS NOT BEEN WORKING FOR THE PAIN LIKE IT SHOULD, OR THAT AT LEAST ONE INS DIED. PATIENT SAID A REPRESENTATIVE (REP) CAME TO THEIR PAIN MANAGEMENT HEALTHCARE PROFESSIONAL (HCP) BUT THE REP DIDN'T KNOW ANYTHING ABOUT THE DEVICES. IT WAS REVIEWED THE PATIENT'S DEVICE IS OFF LABEL AND REVIEWED REP'S ROLE IN OFF LABEL SITUATIONS. PATIENT SAID THEY WANTS A REP TO BE AT THE APPOINTMENT BECAUSE THE NURSES BOTCH UP BADLY MEANING THE NURSE MESSES UP. PATIENT ALSO SAID AFTER THE DEVICES ARE IMPLANTED THE REP WAS ALWAYS THERE AND PROGRAMS THE DEVICES. PATIENT WAS REDIRECTED TO FOLLOW UP WITH HCP TO SCHEDULE AN APPOINTMENT TO HAVE THE DEVICES CHECKED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230675 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR