BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2491675 · Received March 14, 2012

    Report

    Report Number
    3004209178-2012-01572
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    September 2, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3391S-40 LOT #V159340 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; EXTENSION MODEL 7482A51 SERIAL #(B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA; PLUG ADAPTOR MODEL 3550-09 LOT #N193799 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; PLUG ADAPTOR MODEL 3550-09 LOT #N250564 IMPLANTED: (B)(6) 2010 EXPLANTED: NA; PLUG ADAPTOR MODEL 3550-09 LOT #N133836 IMPLANTED: (B)(6) 2010 EXPLANTED: NA; RIGHT STIMULATOR SYSTEM: NEUROSTIMULATOR MODEL 7428 SERIAL #(B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: (B)(6) 2011; LEAD MODEL 3391S-40 LOT #V159340 IMPLANTED: (B)(6) 2009 EXPLANTED: NA; EXTENSION MODEL 7482A51 SERIAL #(B)(4) IMPLANTED: (B)(6) 2009 EXPLANTED: NA; PLUG ADAPTOR MODEL 3550-09 LOT #N177550 IMPLANTED: (B)(6) 2010 EXPLANTED: NA; PLUG ADAPTOR MODEL 3550-09 LOT #N193799 IMPLANTED: (B)(6) 2010 EXPLANTED: NA; THIS DEVICE WAS BEING USED IN A CLINICAL TRIAL NOTED AS (B)(4). ANALYSIS OF NEUROSTIMULATOR MODEL 7428 SERIAL #(B)(4) SHOWED NO SIGNIFICANT ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES (<250 OHMS) WERE MEASURED BETWEEN ELECTRODE #0 AND 3 OF THE PATIENT'S LEFT IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. THE CONNECTIONS WERE CHECKED AND THE PATIENT WAS REPROGRAMMED. THE PATIENT HAD NO SYMPTOMS ASSOCIATED WITH THIS FINDING. ON (B)(6) 2011, THE LEFT INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE RIGHT INS WAS REPLACED AT THE SAME TIME FOR NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE LOW IMPEDANCE PERSISTED FOLLOWING THE INS REPLACEMENT AND THE PATIENT WAS REPROGRAMMED AROUND THE AFFECTED ELECTRODES. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    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 00056 YR