BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1202186 · Received October 16, 2008

    Report

    Report Number
    3004209178-2008-06612
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    March 1, 2008
    Report Date
    September 16, 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION DURING PROGRAMMING IN MARCH. THE SHOCKING WAS DUE TO A PROBLEM WITH 8840 PROGRAMMER THAT LEFT THE MANUFACTURER REPRESENTATIVE UNABLE TO TURN THE STIMULATION OFF. THE PT HAD TO USE THE PT PROGRAMMER TO TURN THE STIMULATION OFF. THE PATIENT'S PROGRAMMING WAS LOST, AND SUBSEQUENT PROGRAMMING HAS NOT BEEN ABLE TO RECAPTURE THE THERAPEUTIC STIMULATION PATTERNS. THE RESULT WAS STIMULATION IN THE WRONG LOCATION AND A LOSS OF THERAPY. AN X-RAY WAS TAKEN. THE LEADS HAD NOT MOVED. THE PT WAS BED RIDDEN FOR FIVE DAYS POST SHOCKING. THE PT WAS IN FAIR CONDITION AT THE TIME OF THE REPORT. THE PT WAS SCHEDULED TO SEE THE PHYSICIAN. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37742| IMPLANTED:| EXTENSION: MODEL 37083| EXPLANTED:| RECHARGER SYSTEM: MODEL 37752| EXPLANTED:| LEAD: MODEL 3986A