BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 2081412 · Received April 22, 2011

    Report

    Report Number
    6000153-2011-03006
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    October 4, 2010
    Report Date
    February 1, 2011
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, WHEN THE LEAD KIT WAS OPENED, THE PHYSICIAN OBSERVED THAT THE ELECTRODE #0 AND THE TIP OF THE LEAD WERE BENT OUT OF ALIGNMENT WITH THE OTHER ELECTRODES. ANOTHER LEAD WAS THEN IMPLANTED WITHOUT FURTHER INCIDENT. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MPROC, VILLALBA 3387-40 V526048

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR