BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4334134 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24051
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# VA0NWKD, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED HER PAIN HCP (HEALTHCARE PROVIDER) TOLD HER IT WAS OK TO USE THE HEATING PAD. SHE USED THE HEATING PAD ON HER UPPER-MID BACK THE DAY BEFORE REPORTED EVENT DATE AND FELT THAT HER NEUROSTIMULATOR WAS ON FIRE. THE PATIENT FELT THE NERVE THAT WAS CONNECTED TO HER SPINE WAS ON FIRE. SHE FELT NEUROSTIMULATOR WAS ON FIRE AND BURNING, IT WAS HURTING BAD WHERE INC ISION WAS. HER INCISION WAS ABOVE HER LEFT BUTT CHEEK. SHE DID NOT HAVE THE HEATING PAD ON INS, SHE HAD IT ABOVE IT. SHE ALSO STATED, SHE HAD BEEN IN PAIN SINCE IMPLANTED. PAIN WAS WHERE INCISION WAS AND AT NERVE ENDINGS. HER LOWER BACK WAS IN PAIN TOO. SHE ALSO HAS A NEUROPATHY AND HAD THAT SURGERY AND MAYBE THAT'S WHAT SHE WAS FEELING. THE PATIENT REPORTS NO STIMULATION SENSATION. SHE FEELS NO STIMULATION. SHE STOPPED FEELING STIMULATION A WEEK AGO. SHE TALKED TO A MANUFACTURER REPRESENTATIVE 2 WEEKS AGO AND SHE TOLD HER TO WAIT FOR ABOUT 2 WEEKS BEFORE SHE CAN INCREASE STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824328 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR