BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2474177 · Received March 1, 2012

    Report

    Report Number
    3004209178-2012-01284
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    May 12, 2010
    Report Date
    July 6, 2010
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3391S-40, LOT #V159340, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. IN-LINE CONNECTOR (EXTENSION): MODEL 3550-05, LOT #N231683, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. EXTENSION: MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PLUG/BOOT ACCESSORY: MODEL 3550-09, LOT #N204408, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. RIGHT SYSTEM: NEUROSTIMULATOR MODEL 7428, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. LEAD: MODEL 3391S-40, LOT #V159369, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. IN-LINE CONNECTOR (EXTENSION): MODEL 3550-05, LOT #N231690, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. EXTENSION: MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PLUG/BOOT ACCESSORY: MODEL 3550-09, LOT #N204408, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. THIS DEVICE WAS BEING USED IN A CLINICAL TRIAL NOTED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT DURING INTERROGATION OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) IT WAS OBSERVED THAT THE CYCLING PARAMETERS OF THE RIGHT INS HAD INCREASED BY 30 MINUTES SINCE THE LAST INTERROGATION IN (B)(6) 2010. SPECIFICALLY, THE CYCLING START TIME CHANGED FROM 6:30 TO 7:00 AND THE CYCLING STOP TIME CHANGED FROM TO 22:00 TO 22:30. REPROGRAMMING WAS PERFORMED ON (B)(6) 2010 AND WITH THE PATIENT OUTCOME REPORTED AS RECOVERED WITHOUT SEQUELAE. IT WAS THEN REPORTED THAT DURING INTERROGATION ON (B)(6) 2010, IT WAS OBSERVED THAT THE CYCLING PARAMETERS ON THE LEFT INS INCREASED BY 30 MINUTES (START TIME CHANGED FROM 6:00 TO 6:30, STOP TIME CHANGED FROM 21:30 TO 22:00) SINCE THE LAST INTERROGATION IN (B)(6) 2010. ON (B)(6) 2010, INTERROGATION OF THE DEVICES SHOWED THAT THE LEFT INS CYCLING PARAMETERS RECEDED BY 30 MINUTES (START TIME CHANGED FROM 6:30 TO 6:00, STOP TIME CHANGED FROM 22:00 TO 21:30) SINCE THE LAST INTERROGATION ON (B)(6) 2010. REPROGRAMMING WAS THEN PERFORMED ON (B)(6) 2010 WITH THE OUTCOME 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 00044 YR