BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 1972393 · Received January 20, 2011

    Report

    Report Number
    3004209178-2011-00510
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    January 7, 2011
    Report Date
    March 20, 2014
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DEVICE DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR. THE DEVICE SETTINGS WERE 1 PROGRAM, 3.9V, 450MCS, 40HZ, 0-, 1-, 2+, 8+, 9+, 10+. THE DEVICE WAS USED 16 HOURS PER DAY WITH 2 SECONDS ON/2 SECONDS OFF CYCLING. IMPEDANCE TESTING REVEALED A SHORT WITH ELECTRODE PAIR 1,9 AND THE GROUP IMPEDANCE WAS LESS THAN 50 OHMS. EXCLUDING THE SHORT, LONGEVITY WAS ESTIMATED TO BE 43-48 MONTHS AT THE SAME SETTINGS. PROGRAMMING THE DEVICE WITHOUT USING ELECTRODE 1 OR 9 WAS DISCUSSED. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATED THAT THE INS WAS REPLACED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V238519029| LEAD: MODEL 3778, LOT# V238519030| PROGRAMMER: MODEL 37743, LOT# NKE122081N| LEAD: MODEL 3778, LOT# V238519029| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V238519030| PROGRAMMER: MODEL 37743, LOT# NKE122081N