BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2961501 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02628
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 25, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_INS_PLUG_ACC LOT#, PRODUCT TYPE ACCESSORY PRODUCT ID, 7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 64002 LOT# N315997,# IMPLANTED: 2012 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3389S-40 LOT# V040097, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V021177, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_INS_PLUG_ACC LOT#, EXPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR RESULTED IN NO ANOMALIES FOUND. THE OUTPUT WAS GOOD ON ALL ELECTRODES WITH A KNOWN GOOD EXTENSION AND LEADS. ALL IMPEDANCES WERE WITHIN NORMAL LIMITS ANALYSIS OF THE PLUG RESULTED IN NO ANOMALIES FOUND

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE IN THE RIGHT HEMISPHERE AND ELECTRODE PAIRS WITH ELECTRODE 6 SHOWED IMPEDANCE VALUES GREATER THAN 4000. IT WAS NOTED THAT STIMULATION WAS IN THE WRONG LOCATION. IT WAS REPORTED THAT THE PATIENT ALSO HAD SPASMS AND MUSCLE CONTRACTIONS IN THE LEFT PECTORALIS WHEN THE LEFT ARM WAS PLACED IN CERTAIN RAISED POSITIONS, WHICH WAS CONFIRMED BY A PHYSICAL EXAMINATION BY THE PATIENT'S NEUROSURGEON. THE REPORTER STATED THAT THERE WAS NO BURNING, SHOCKING, OR TINGLING. IT WAS REPORTED THAT THE PATIENT HAD REDUCED THERAPY, BUT NOT LESS THAN 50 PERCENT. DIAGNOSTIC TESTING AND TROUBLESHOOTING WAS PERFORMED, AND SURGICAL EXPLORATION REVEALED POSSIBLE FLUID IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. IMPEDANCE TESTS "FROM THE POCKET ADAPTOR AND HIGHER" REVEALED NORMAL VALUES. THIS MAY HAVE REFERRED TO IMPEDANCE TESTS OF THE COMBINATION OF THE POCKET ADAPTOR, EXTENSIONS, AND LEADS. THE INS WAS EXPLANTED AND REPLACED, AND SUBSEQUENT IMPEDANCE TESTS SHOWED NORMAL VALUES. IT WAS REPORTED THAT THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65421 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention