BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1213279 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06892
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THIS REPORT IS BEING SUBMITTED LATE, DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S STIMULATION STOPPED WORKING. IT WAS CHECKED AND THE BATTERY WAS DEPLETED. THE PT'S DEVICE WAS REPLACED. THERE WAS CONCERN THAT THE BATTERY DEPLETED TOO QUICKLY. THE PT'S PRIOR DEVICE LASTED FOR FIVE YEARS; THIS DEVICE LASTED ONE YEAR. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention EXTENSION MODEL 7495-51| LEAD MODEL 3888| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL UNK| PROGRAMMER MODEL 7434| EXPLANTED: