BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7243517 · Received February 6, 2018

    Report

    Report Number
    3004209178-2018-02123
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    March 1, 2016
    Report Date
    February 6, 2018
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V141293, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# VA0Z1EF, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2017, 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 WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN HER LOWER BACK AND RADIATING TO HER HIP. SHE WAS SURE THAT IT WAS FROM THE LEAD WIRE. SHE HAD ALREADY TURNED IMPLANT OFF TO SEE IF THAT WOULD RESOLVE THE ISSUE BUT IT HAD NOT. THE ISSUE HAD BEEN GOING ON FOR OVER A WEEK. SHE CONTACTED HEALTHCARE PROVIDER (HCP) BUT HAS NOT HEARD BACK FROM HCP YET. THE EVENT OCCURRED IN (B)(6) 2016. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT SAID THEY WERE HAVING SERIOUS ISSUES WITH THE INS WIRE/LEAD. PATIENT SAID PRIOR TO THE REPORT, THEY TURNED THE INS OFF AND THEY WERE STILL IN EXCRUCIATING PAIN FROM THE WIRE/LEAD. PATIENT SAID THEY HAD GONE TO THE EMERGENCY ROOM (ER) TWICE FOR THE PAIN BECAUSE THEY COULD NOT STAND THE PAIN. PATIENT SAID THEY JUST REALIZED ON SATURDAY THAT THE LEAD MAY BE WHAT WAS CAUSING THEM PAIN ABOVE THEIR RIGHT HIP. PATIENT SAID THEY NEEDED THE INS TAKEN OUT BECAUSE THEY COULD NOT STAND THE PAIN ANY LONGER. PATIENT WAS REDIRECTED TO THE HEALTH CARE PROFESSIONAL (HCP) TO DISCUSS REMOVAL AND HAVE THE DEVICE CHECKED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS ASKED TO CLARIFY THE PAIN ABOVE THEIR RIGHT HIP AND RESPONDED THAT THE DEVICE WAS AN IS SUE FOR THEM BECAUSE AS SOON AS THE WIRE WAS REMOVED, THEY NO LONGER HAD ANY PAIN. ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE PAIN WAS DEVICE REMOVAL THAT OCCURRED ON (B)(6) 2017. IT WAS FURTHER REPORTED THAT AFTER A MONTH OF AGONIZING PAIN, ONCE THE DEVICE WAS REMOVED, THEY NO LONGER HAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88612 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention