BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3843213 · Received June 2, 2014

    Report

    Report Number
    3007566237-2014-01498
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL PATIENT WAS HAVING PAIN AND IT STARTED A DAY AFTER THEY PUT THE PERIPHERAL NERVE EVALUATION (PNE) IN THEM. THE PATIENT CLARIFIED THAT THEY HAD A SCIATIC NERVE INJURY AND IT FELT LIKE SHOOTING UP AND DOWN. IT WAS NOTED THAT THE PATIENT HAD TRIED TO ADJUST THE STIMULATION BUT IT HADN¿T HELPED THEM. EVERY DAY THE PATIENT WOKE UP THEIR PARENT HAD TO PHYSICALLY HELP THEM UP BECAUSE THEY WERE TOO WEAK. IT WAS REPORTED THAT THE PATIENT HAD CONTACTED THEIR HEALTH CARE PROVIDER (HCP) AND THEY TOLD THEM TO CALL THE MANUFACTURER. THE PATIENT WAS SCHEDULED TO HAVE IT REMOVED TOMORROW AND THE PERSON WHO PUT IT IN TOLD THE PATIENT THAT THEY COULD TRY THE OTHER SIDE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S TRIAL WAS NOT SUCCESSFUL AS THEY WERE HAVING TOO MUCH SCIATIC NERVE PAIN AND HAD THE TRIAL REMOVED A DAY EARLY AND WOULD NOT GO ONTO IMPLANT. THE PATIENT¿S SCIATIC PAIN RESOLVED AFTER REMOVAL OF THE TRIAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321527 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention