BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3961564 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13594
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 2, 2014
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REPLACEMENT OF THE RIGHT SIDE PRIMARY CELL DEVICE. THERE WAS A ¿PREVIOUS BATTERY MALFUNCTION.¿ IT WAS LATER REPORTED THAT THERE WAS A BATTERY MALFUNCTION. PATIENT¿S DISORDER INDICATION WAS TREMORS. THE PATIENT WAS A HOSPITAL INPATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE REPLACEMENT OF THE RIGHT SIDE DEVICE WAS ON (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439142 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R