BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1854113 · Received September 30, 2010

    Report

    Report Number
    3004209178-2010-07503
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S DEVICE "WENT BACK" TO THE FACTORY SETTING 1 MONTH POST IMPLANT. SINCE THEN, THE PT SAID HE HAD BEEN LOSING STIMULATION "OFF AND ON," AND WHENEVER HE CHECKED HIS PT PROGRAMMER THE STIMULATION WAS "ON." IN ADDITION, THE PT HAD A POWER ON RESET (POR). THE POR OCCURRED 2 MONTHS POST-IMPLANT, AND THE PT STATED HE WAS TOLD HIS STIMULATOR WAS "FAULTY" AND SUFFERED FROM THE "WIREBOND ISSUE." ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT WORK FOR 3 YEARS AND WAS REMOVED ABOUT A MONTH AGO. IT WAS NOTED THAT THE PATIENT WAS AWAKE DURING THE SURGERY AND HEARD THAT THE INS WAS THE PROBLEM AND NOT THE LEAD COMPONENTS. IT WAS FURTHER STATED THAT THE LEADS WERE DEFECTIVE BUT TESTING AT SURGERY SHOWED THAT ¿THE WIRES WERE GOOD¿ AND THAT THE BATTERY WAS ¿BAD¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PROGRAMMER: MODEL 7436, LOT# NFU023396P| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU189058V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V221331| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V221331| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU198048V