BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2003743 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01403
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    April 1, 2009
    Report Date
    February 8, 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 ORIGINALLY REPORTED THAT THE PATIENT HAD FALLEN IN (B)(6) 2009, AND HAD A "THROMBOSIS". IT WAS NOTED THAT HIS STIMULATION HAD BEEN TURNED OFF FOR OVER A YEAR. HIS LEGS WERE NOTED AS "SWOLLEN AND RED AND PURPLE". AT THAT TIME, THE PATIENT WAS IN FAIR CONDITION AND WAS IN A LONG-TERM CARE FACILITY. THE COMPANY REPRESENTATIVE MET WITH THE PATIENT IN (B)(6) 2009, AND AN OVERDISCHARGE CONDITION ON THE PATIENT'S DEVICE WAS SUSPECTED AND IT WAS REPORTED THAT THIS WAS HIS SECOND OR THIRD OVERDISCHARGE CONDITION. HE LAST HAD STIMULATION IN (B)(6) 2009, AND THE OVERDISCHARGE SITUATION WAS ATTRIBUTED TO PATIENT NON-COMPLIANCE AND SOME "PERSONAL ISSUES". THE PATIENT HAD THE NEUROSTIMULATOR REPLACED (WITH A NON-RECHARGEABLE TYPE) DUE TO THE OVERDISCHARGE CONDITION AND WAS REPORTED AS RECEIVING THERAPY WITHOUT ANY FURTHER PROBLEMS.

    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 62 YR Required Intervention LEAD: MODEL 3778, LOT# V048364026| PROGRAMMER: MODEL 37742, LOT# NJD054299N| LEAD: MODEL 3778, LOT# V048364027| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA032586N| IMPLANTED:| IMPLANTED:| EXPLANTED: