BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD KIT

    MDR report key: 1032201 · Received April 21, 2008

    Report

    Report Number
    6000153-2008-02094
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AN X-RAY AND CT SCAN (DATES NOT REPORTED REVEALED THAT HE HAS A LEAD FRACTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT NUMBERS: 6000153-2007-04058; 6000153-2007-04059; 6000153-2008-02095.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD KIT MHY MEDTRONIC PUERTO RICO OPERATIONS 3387S V010026

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| LOT# NFD104604H| IMPLANTED| PROGRAMMER MODEL 7436| IMPLANTED| IMPLANTED| EXTENSION MODEL 748251| LEAD MODEL 3387S| EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7428| EXTENSION MODEL 748251| EXPLANTED