BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1031333 · Received April 18, 2008

    Report

    Report Number
    6000153-2008-02052
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBSEQUENT TO REPLACEMENT OF THE PULSE GENERATOR THE PATIENT HAD EXPERIENCED A LACK OF THERAPEUTIC EFFECT; THERE HAD BEEN A WORSENING OF PARKINSON'S SYMPTOMS (NOT SPECIFIED). THE STIMULATION SETTINGS HAD BEEN ADJUSTED (DATE OF FOLLOW-UP FOR REPROGRAMMING WAS NOT REPORTED. WHEN NO IMPROVEMENT WAS DETECTED, THE PATIENT UNDERWENT EXPLORATORY SURGERY AS AN OUTPATIENT PROCEDURE. INSPECTION REVEALED THAT FLUID HAD ENTERED THE CONNECTOR BLOCK WHERE THE EXTENSION DEVICES CONNECT TO THE PULSE GENERATOR AND BOTH EXTENSION WIRES ALONG WITH THE PULSE GENERATOR WERE REPLACED. THE PATIENT SUBSEQUENTLY RECEIVED ADEQUATE STIMULATION THERAPY CONTROL; HIS SYMPTOMS HAD IMPROVED AND THE PATIENT WAS DISCHARGED TO HOME TWO DAYS LATER. REFER TO MFR REPORT #6000153200802051

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R SINEMET 25/100| LEAD MODEL 3387 LOT# J0421698V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# J0421698V| EXPLANTED:| LEAD MODEL 3387 LOT# J0421698V| IMPLANTED: