BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2172364 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04739
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 31, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT EXPERIENCED TELEMETRY ISSUES AND A POSSIBLE OVER-DISCHARGE CONDITION WITH HIS IMPLANTABLE NEUROSTIMULATOR (INS). SUBSEQUENTLY, A POWER-ON-RESET (POR) CONDITION WITH A END-OF-SERVICE (EOS) / END-OF-LIFE (EOL) MESSAGE ON THE PROGRAMMER. IT WAS NOTED THAT THIS WAS DUE TO PT NEGLECTING TO RECHARGE HIS DEVICE AND IT WAS HIS THIRD OCCURRENCE. THE INS WAS THEN REPLACED WITH A NON-RECHARGABLE. IT WAS REPORTED THAT THE PT WAS RECEIVING EFFECTIVE STIMULATION AFTER THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE122295N| EXPLANTED:| LEAD: MODEL 3778, LOT# V203126033| ACCESSORY: MODEL 37752, LOT# NKA123504N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V198016014| EXPLANTED: