BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1191114 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06162
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AREA AROUND THE STIMULATOR WAS EXTREMELY SENSITIVE AND WARM TO THE TOUCH. IT WAS ALSO REPORTED THAT THE STIMULATOR GOT HOT WHEN IT WAS OPERATING AND DURING ESPECIALLY HOT DURING RECHARGING. IT HURT THE SKIN TO THE POINT THE PATIENT KEPT THE DEVICE TURNED OFF. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 42 YR Required Intervention IMPLANTED:| RECHARGER: MODEL 37752| IMPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| PROGRAMMER: MODEL 37742| LEAD: MODEL 39565| IMPLANTED:| EXPLANTED: