BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2472905 · Received February 29, 2012

    Report

    Report Number
    3004209178-2012-01261
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    March 1, 2010
    Report Date
    March 2, 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, EXTENSION MODEL 7482A51 (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: NA, IN-LINE CONNECTOR EXTENSION MODEL 3550-05 LOT #N231683 IMPLANTED: (B)(6) 2010 EXPLANTED: NA, PLUG/BOOT ACCESSORY MODEL 3550-09 LOT #N204408 IMPLANTED: (B)(6) 2010 EXPLANTED: NA, RIGHT SIDE SYSTEM: NEUROSTIMULATOR MODEL 7428 (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: (B)(6) 2011, LEAD MODEL 3391S-40 LOT V159369 IMPLANTED: (B)(6) 2010 EXPLANTED: NA, EXTENSION MODEL 7482A51 (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: NA, IN-LINE CONNECTOR EXTENSION MODEL 3550-05 LOT #N231690 IMPLANTED: (B)(6) 2010 EXPLANTED: NA, PLUG/BOOT ACCESSORY MODEL 3550-09 LOT #N204408 IMPLANTED: (B)(6) 2010 EXPLANTED: NA. THIS DEVICE WAS BEING USED IN A CLINICAL TRIAL NOTED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES (>4000 OHMS) WERE SEEN ON ALL COMBINATIONS WITH ELECTRODE #2 OF THE LEAD THAT WAS PART OF THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WHEN FIRST INTERROGATED. IT WAS NOTED DURING THE INTERROGATION THE HIGH IMPEDANCE WERE POSITIONAL. SPECIFICALLY, WHEN THE PATIENT TURNED HIS HEAD TO THE LEFT, IMPEDANCES OF 1883 OHMS WERE OBSERVED. WHEN HE TURNED HIS HEAD TO THE RIGHT, IMPEDANCES OF 2830 OHMS WERE SEEN. THE HIGH IMPEDANCES WERE RESOLVED SUBSEQUENTLY FOLLOWING INS REPLACEMENT. 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 00044 YR Required Intervention