BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1913549 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09434
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED COUPLING AND/OR COMMUNICATION ISSUES. THE PT FELL ON (B)(6) 2010, AND THE DEVICE DID NOT WORK AFTER THAT. THE PT DID NOT RECHARGE THE DEVICE IN THREE TO FOUR WEEKS PRIOR TO THIS REPORT. IT WAS SUSPECTED THAT AN OVER-DISCHARGE CONDITION EXISTED. THE STIMULATION WAS NOT ADJUSTED IN THE PREVIOUS THREE MONTHS. IT WAS SUGGESTED THAT THE INS HAD FLIPPED, BUT THIS WAS NOT CONFIRMED. IT WAS LATER REPORTED THAT THE PT WAS NOT ABLE TO ADJUST THE STIMULATION. A "CALL YOUR DOCTOR" ICON WAS DISPLAYED AND A POWER ON RESET (POR) CONDITION EXISTED. A WARNING POR WAS RECEIVED AFTER A PHYSICIAN MODE RECHARGE (PMR). THE PT WAS TO CONTACT THE MANUFACTURER REPRESENTATIVE TO SET UP AN APPOINTMENT TO CLEAR THE WARNING POR USING A MODEL 8840 PHYSICIAN PROGRAMMER. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB004143N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT # J0546520V| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB004142N| PROGRAMMER: MODEL 37742, LOT # NJD011824N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT # N0029853| IMPLANTED: