BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2802765 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09465
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 2, 2012
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # V695788, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID 3889-28, LOT # V738951, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4) PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A "WEIRD PAIN IN THE LOWER BACK AND INTO HER BUTT." THE REPORTER STATED ONSET WAS 15 MINUTES PRIOR TO REPORT, WHILE EATING. IT WAS STATED THE PATIENT WAS SITTING IN HER CAR, UNABLE TO MOVE, AND DID NOT KNOW IF SHE WAS RECEIVING STIMULATION. IT WAS STATED THE PATIENT "THINKS HER INS (IMPLANTABLE NEUROSTIMULATOR) WAS ON." IT WAS STATED THAT THERE WERE NO TRAUMA OF FALLS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT BELIEVED "THE DEVICE ITSELF WAS MESSING WITH HER NERVE." THE PATIENT ALSO REPORTED THAT "WHEN SHE FIRST GOT THE DEVICE IT FELT STRANGE." ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER (HCP) INDICATED THAT THE PATIENT'S LEAD HAD MIGRATED AND A LEAD REVISION WAS PERFORMED ON (B)(6) 2012. THE PATIENT REPORTED PAIN. THE PATIENT RECOVERED WITHOUT SEQUELA. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2012-09434.

    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 Required Intervention