BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2850999 · Received November 29, 2012

    Report

    Report Number
    3007566237-2012-02865
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3387S-40, LOT# V218104, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V175997, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    AN INCREASE IN PATIENT'S TORTICOLLIS OF NECK DUE TO DYSTONIA WHEN HE WALKED WAS REPORTED. THE SETTINGS ON BOTH LEFT AND RIGHT SIDE IMPLANTABLE NEUROSTIMULATORS (INS) WERE 5.0V AMPLITUDE WITH PULSE WIDTH OF 150 MICROSECONDS AND THE RATE OF 50HZ. LEFT SIDE INS IMPEDANCE WAS 827 OHMS, RIGHT SIDE INS IMPEDANCE MEASUREMENT WAS NOT AVAILABLE. BOTH STIMULATORS WERE AT 3.72V AT TIME OF IMPLANT. IN (B)(6) 2011 BOTH WERE AT 3.72V, IN (B)(6) 2011 BOTH WERE AT 3.72V. AT THE TIME OF THE REPORT ONE INS WAS AT 3.60V AND THE OTHER WAS AT 3.66V. LONGEVITY ESTIMATE "SHOWED 30 MONTHS." IT WAS NOTED THAT THE DEVICES WERE "PAST THE 30 MONTH ESTIMATE." NORMAL BATTERY DEPLETION WAS REPORTED ABOUT FOUR MONTHS LATER. THE DEVICE WAS REPLACED. THE PATIENT WAS HOSPITALIZED FOR ONE NIGHT DUE TO PAIN. INFORMATION ALSO REPORTED ON PATIENT'S OTHER INS IN REGULATORY REPORT # 3004209178-2012-10923.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S PROCEDURE WAS AN 'OUTPATIENT BATTERY REPLACEMENT.' REFER TO MANUFACTURER REPORT # 3004209178-2012-10923.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization