BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1071732 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03881
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED COMMUNICATION ISSUES. THE PROGRAMMER SHOWED ALL BARS PRESENT, BUT NONE WERE BLACKENED. TROUBLESHOOTING WAS DONE WITHOUT SUCCESS. AN X-RAY REVEALED THE INS HAD FLIPPED. THE PT WAS SCHEDULED TO SEE THE SURGEON FOR OPTIONS REGARDING THE DEVICE FLIP. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 61 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 37081| PROGRAMMER: MODEL 37742| EXPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: