BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2482720 · Received March 7, 2012

    Report

    Report Number
    3004209178-2012-01420
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    January 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR MODEL 7428 SERIAL# (B)(4) FOUND NO ANOMALY. CONTINUED FROM CONCOMITANT MEDICAL PRODUCTS. LEAD MODEL 3389S-40 LOT# V043266 IMPLANTED (B)(6) 2007 EXPLANTED UNK; LEAD MODEL 3389S-40 LOT# V043266 IMPLANTED (B)(6) 2007 EXPLANTED UNK; EXTENSION MODEL 7482A95 SERIAL# (B)(4) IMPLANTED (B)(6) 2007 EXPLANTED UNK; EXTENSION MODEL 7482A95 SERIAL# (B)(4) IMPLANTED (B)(6) 2007 EXPLANTED UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND PROBLEMS WITH BALANCE. ADDITIONAL INFORMATION RECEIVED REPORTED THE NEUROSTIMULATOR WAS REPLACED DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention