BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTREL 3

    MDR report key: 1083377 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04455
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE FELL SOME TIME AGO. SHE WAS EXPERIENCING PAIN IN HER ARM, HEADACHES, VOMITING, AND NO STIMULATION SENSATION; SHE WAS UNABLE TO ADJUST STIMULATION. THE PATIENT WAS AT HOME. HER STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. THE PATIENT WAS ENCOURAGED TO CONTACT HER HEALTH CARE PROFESSIONAL. 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 INTREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention EXTENSION MODEL 7489 LOT# NHU05828V| EXPLANTED:| IMPLANTED| LEAD MODEL 3986A LOT# LB9823| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 7434A LOT# NGL016181P