BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2873491 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11822
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 14, 2010
    Report Date
    May 17, 2016
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V525448, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT FELT ELECTRIC SHOCKS IN HER LEGS; FROM THE MIDDLE OF HER LEG DOWN, AND IN HER GROIN AT THE TIME. THE PATIENT HAD HER STIMULATION ADJUSTED AND WAS "GIVEN 4 OTHER PROGRAMS" BUT THE SHOCKS IN HER LEGS MOVED TO A DIFFERENT LOCATION. THE PATIENT WAS REPORTED TO HAVE WET HER BED 5 NIGHTS BEFORE AND HAD NOT SEEN THE IMPROVEMENT OR VERY LITTLE IMPROVEMENT SINCE SHE GOT THE IMPLANT. THE PATIENT EXPERIENCED PAIN "OVER THE IMPLANT", IN THE BUTTOCK AREA "ALL AROUND THE METAL" AND RECENTLY THE AREA WAS HURTING MORE. IT WAS NOTED THAT THE PATIENT COULD NOT STAND THE PAIN. IT WAS ALSO INDICATED THAT THE PATIENT BELIEVED HER BODY WAS REJECTING THE IMPLANT, DID NOT WANT IT AND WANTED TO HAVE SURGERY TO HAVE THE DEVICE REMOVED. SINCE THE IMPLANT, THE PATIENT HAD NEVER FELT GOOD AND STILL DID NOT FEEL GOOD, BUT IT STARTED GETTING WORSE 6 MONTHS BEFORE. THE PATIENT WAS SCHEDULED TO SEE A HEALTHCARE PROVIDER (HCP) ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE INS WAS TURNED OFF. THE PATIENT INDICATED THE HEALTHCARE PROVIDER (HCP) TOLD HER SHE COULD NOT HAVE IT REMOVED AS IT COULD CAUSE HER HARM IN HER SPINE IF REMOVED. THE ISSUE WAS INDICATED TO HAVE BEGUN (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR