BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1213817 · Received October 28, 2008

    Report

    Report Number
    3004209178-2008-06959
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 30, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO RECHARGE THEIR STIMULATOR. THE PATIENT WAS HAVING TROUBLE WITH COUPLING ISSUES. THE PATIENT WAS SEEN IN THE CLINIC. TROUBLESHOOTING WAS ATTEMPTED. THE INS COULD BE FELT IN THE POCKET BUT STILL NO COUPLING BARS WERE NOTED. THE INS WAS SUSPECTED TO BE FLIPPED IN THE POCKET. THE INS WAS LATER CONFIRMED TO BE FLIPPED UNDER FLUOROSCOPY. THE PATIENT WAS SCHEDULED FOR A PROCEDURE TO CORRECT THE INS POSITION. THERE WERE NO FURTHER ADVERSE EVENTS. THE DATE OF THE SURGERY WAS NOT REPORTED.

    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 Required Intervention PROGRAMMER: MODEL 37743| LEAD: MODEL 3998| EXTENSION: MODEL 37082| ACCESSORY: MODEL 37752| EXPLANTED:| LEAD: MODEL 3888| EXPLANTED:| LEAD: MODEL 3888| EXPLANTED:| EXPLANTED:| EXPLANTED: