BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2021813 · Received February 25, 2011

    Report

    Report Number
    3004209178-2011-01467
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE INS WAS OVER-DISCHARGED DUE TO PATIENT'S HEALTH ISSUES. A PHYSICIAN MODE RECHARGE WAS COMPLETED AND THE PATIENT WENT HOME TO FULLY RECHARGE THE INS. AFTER CHARGING THE SYSTEM FULLY IT STARTED TO "SHOCK" THE PATIENT AND THE PATIENT COULD NOT TURN IT OFF. THE REPRESENTATIVE MET THE PATIENT IN THE EMERGENCY ROOM AND USED THE 8840 PHYSICIAN PROGRAMMER TO CLEAR THE POWER ON RESET MESSAGE. THE INS SAID IT WAS OFF BUT WAS STILL SHOCKING THE PATIENT. REPRESENTATIVE TURNED THE INS ON AND "SHOCKING" SENSATION STOPPED. THE INS APPEARS TO BE WORKING FINE NOW. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA119018N| EXPLANTED:| LEAD: MODEL 3778, LOT# V148572021| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# V165192| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE117756N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V165192| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB015493N