BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3562063 · Received January 8, 2014

    Report

    Report Number
    3004209178-2014-00353
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Report Date
    December 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V752271, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40 LOT# V752271, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TIGHTNESS OF THE NECK THAT BEGAN 6 WEEKS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A VERY TIGHT NECK AND PAIN OF THE OCCIPITAL AREA, BILATERALLY. IT WAS NOTED THAT THESE SYMPTOMS WERE FOUND ON BOTH THE RIGHT AND LEFT SIDE OF THE NECK. NO PATIENT FALL OR TRAUMA WAS REPORTED. IT WAS NOTED THAT AN IMPEDANCE TEST WAS PERFORMED AND REVEALED THAT SEVERAL CONTACTS WERE OUT OF RANGE. IT WAS NOTED THAT THE SYSTEM INCLUDING THE EXTENSION AND LEAD APPEARED TO BE INTACT. IT WAS NOTED THAT THE PATIENT DID HAVE NECK PAIN, BUT NO RADICULAR SYMPTOMS INTO THE PATIENT¿S ARM. IT WAS NOTED THAT THE PATIENT DID HAVE A GREATER OCCIPITAL NERVE BLOCK 3 OR 2 WEEKS PRIOR TO THE REPORT, BUT THAT ONLY HELPED FOR 3-4 DAYS AND THE PAIN CAME BACK. IT WAS NOTED THAT THE PATIENT FELT AS IF THE PAIN WAS ALONG THE WIRES AND WENT BACK AND ABOVE THE HEAD. IT WAS NOTED THAT THE PATIENT¿S TREMOR WAS CONTROLLED VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12545 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR