BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1834447 · Received September 10, 2010

    Report

    Report Number
    3004209178-2010-06934
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    May 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 (B)(6), 2010 THAT THE PATIENT WAS RECHARGING ALL DAY NOT GETTING THE BATTERY FULL. CALLER REPORTED COUPLING AND OR COMMUNICATION ISSUES AND CHARGING MORE THAT EXPECTED. THE PATIENT WAS STILL HAVING PROBLEMS WITH HER DEVICE SYSTEM. MEETING (B)(6), 2010 AS STILL NOT WORKING OR CHARGING RIGHT. CAN'T WORK WITHOUT CHARGING FOR ALL DAY AND ONLY CAN USE 5 DAYS AT A TIME THEN CHARGE ALL DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 45 YR LEAD: MODEL 3778, LOT# V416777030| ACCESSORY: MODEL 37752, LOT# NKA135542N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V416780007| PROGRAMMER: MODEL 37743, LOT# NKE144459N