BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2171018 · Received June 30, 2011

    Report

    Report Number
    3004209178-2011-04954
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 28, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN THE STIMULATION WAS TURNED ON DURING POSITIONAL CHANGES. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO ONSET OF THIS PROBLEM. THE LEAD WAS PLACED CERVICALLY. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 OHMS WITH THE BIPOLAR PAIRS AT 0.7V WHILE USING ELECTRODE 2. AT 1.5V, THE IMPEDANCES WERE 16,000 - 17,000 OHMS. IT WAS THOUGHT THAT ELECTRODE #2 WAS NEEDED FOR THERAPY BUT REPROGRAMMING AROUND IT WAS GOING TO BE ATTEMPTED. THE PATIENT WAS AT THE CLINIC IN GOOD CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 NA Female ACCESSORY: MODEL 37752, LOT# NKA145912N| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084971V| EXTENSION: MODEL 37083, LOT# NKC001905V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD: MODEL 3986A, LOT# N239902| PROGRAMMER: MODEL 37743, LOT# NKE157902N| STIM ACCESSORY: MODEL 37092, LOT# 263090001| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 263090001| LEAD: MODEL 3986A, LOT# N239902| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084971V| EXTENSION: MODEL 37083, LOT# NKC001905V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA145912N| PROGRAMMER: MODEL 37743, LOT# NKE157902N| IMPLANTED: