BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2963800 · Received February 15, 2013

    Report

    Report Number
    3007566237-2013-00502
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN OBSERVED THE CONNECTION BETWEEN THE ELECTRODE AND THE EXTENSION WAS "EXTERIORIZED." IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO REPLACE THE EXTENSIONS AND CHANGED THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANT SITE FROM THE LEFT SIDE OF THE CHEST TO THE RIGHT SIDE. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THAT THE EVENT WAS DUE TO AN ALLERGIC REACTION TO THE EXTENSION'S MATERIAL. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS STABLE AND WITHOUT INJURY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68260 NEU_INS_STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention