BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3953564 · Received July 23, 2014

    Report

    Report Number
    3007566237-2014-02066
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA0KHG5, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-05, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3058, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3550-05, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S TRIAL STARTED STAGE 1 ON (B)(6) 2014. OVER THE WEEKEND, 3 DAYS AGO, THE MANUFACTURER REPRESENTATIVE RECEIVED A CALL THAT INDICATED THE PATIENT HAD A TOPICAL REACTION. IT WAS NOTED THAT THE TRIAL PATIENT WENT TO THE EMERGENCY ROOM (ER) AND A HEALTH CARE PROVIDER (HCP) CHANGED THEIR GAUZE AND TAPE AND THE PATIENT WAS TAKING AN ANTIBIOTIC AND CONTINUED TO HAVE A TOPICAL REACTION. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE DID NOT HAVE THE FULL DETAILS. THE PATIENT HAD A TINED LEAD IMPLANTED AND WAS HAVING GREAT SUCCESS. IT WAS REPORTED THAT THE REACTION WAS A TOPICAL ITCHY RASH AND WAS ALL TOPICAL AND NOT INTERNAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TOPICAL RASH WAS NOTICED 6 DAYS AGO DURING THE PATIENT¿S STIMULATION TRIAL. THE PATIENT WAS SEEN IN THE ER FOR THE RASH 2 DAYS LATER AND THEY CHANGED THE GAUZE, ADHESIVE, AND DRESSING THINKING THE PATIENT WAS HAVING A REACTION TO THESE ITEMS BUT THE RASH DIDN¿T RESOLVE. IT WAS NOTED THAT THE PATIENT THOUGHT THEY MAY HAVE A NICKEL ALLERGY BUT THEY HADN¿T HAD ANY ALLERGY TESTING DONE. THE REACTION OCCURRED WHERE THE PATIENT HAD A PERCUTANEOUS EXTENSION COILED UP AGAINST THEIR SKIN. IT WAS NOTED THAT THE PATIENT DIDN¿T HAVE A HISTORY OF METAL ALLERGIES. THEY DID THE TRIAL FOR ABOUT 2 WEEKS AND IT HAD BEEN OVER 2 WEEKS NOW AND THE TOPICAL RASH SHOWED UP AT THE END OF THE TRIAL. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOTIFIED 6 DAYS AGO WHEN THE RASH WAS NOTICED BY THE PATIENT AND THEY WERE DOING THE STAGE 2 TODAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PROCEEDED WITH THE IMPLANT BECAUSE THEY WERE HAPPY WITH THE RESULTS. THE PATIENT IMPROVED 50 PERCENT FROM BASELINE AND THE MANUFACTURER REPRESENTATIVE HAD NO INFORMATION ON THE TREATMENT OF THE TOPICAL RASH. IT WAS NOTED THAT THE IMPLANT WAS DONE ON (B)(6) 2014 AND THE PATIENT HAD A SUCCESSFUL STAGE 2. THE PATIENT WAS DOING GREAT AND WAS RECEIVING EFFECTIVE THERAPY AS FAR AS THEY KNEW TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430608 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention