BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2182284 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05276
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO STIMULATION SENSATION AFTER GOING TO THE GYM. ADD'L INFO 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., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR ACCESSORY: MODEL 37752, LOT #NKA027812N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT #NKC008405N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT #LA1649| EXPLANTED:| EXTENSION: MODEL 37083, LOT #NKC008386N| EXPLANTED:| PROGRAMMER MODEL 37742, LOT #NJD050576N| IMPLANTED:| EXPLANTED: