BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2030182 · Received March 7, 2011

    Report

    Report Number
    3007566237-2011-01705
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT'S DEVICE WAS SHOWING LOW IMPEDANCE READINGS. AFTER THE IMPLANT OF THE PATIENT'S DEVICE, IMPEDANCES WERE CHECKED AND IT WAS FOUND THAT CASE AND #10, AND CASE AND #11 ELECTRODES HAD IMPEDANCES OF 700 OHMS, AND ELECTRODES 10 AND 11 HAD AN IMPEDANCE CHECK OF 34 OHMS. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3387S, LOT# V616863| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| IMPLANTED: