BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2120152 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04000
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A REPROGRAMMING OF THE DEVICE, THE PT EXPERIENCED NO STIMULATION SENSATION IN PROGRAM C. IT WAS LATER REPORTED THAT THE PT MET WITH THE PHYSICIAN AND MANUFACTURER REP REGARDING THIS EVENT. THE DEVICE WAS NOT SUCCESSFULLY REPROGRAMMED AND THE PT STILL HAD PROBLEMS WITH THE DEVICE SYSTEM. THE PT HAD REVISION SURGERY ON (B)(6), 2011, AT WHICH TIME BOTH LEADS WERE REPLACED DUE TO HIGH IMPEDANCE READINGS ON ALL OF THE ELECTRODES. THE LEADS WERE CUT AND WILL NOT BE RETURNED TO THE MANUFACTURER. THE PT WAS DOING "FANTASTIC" FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149234N| EXPLANTED:| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA141646N| IMPLANTED:| LEAD: MODEL 3778, LOT# V417283024| LEAD: MODEL 3778, LOT# V357772014