BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2241069 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06500
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 27, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY ISSUES WERE ENCOUNTERED. THE USE OF THE ANTENNA LOCATOR (AL) FEATURE RESULTED IN A POWER ON RESET (POR) CONDITION DISPLAYED ON THE RECHARGER. THIS, THEN, LED TO THE NORMAL RECHARGING SCREEN. THE PT HAD NOT USED THE STIMULATION FOR THE PAST THREE MONTHS, DUE TO UNSATISFACTORY STIMULATION. IT WAS POSSIBLE TO RECHARGE NORMALLY AFTER USING THE AL FEATURE. NO INFORMATION WAS PROVIDED RELATED TO THE PT'S OUTCOME. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 53 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149668N| RECHARGER: MODEL , LOT# NKA140382N| LEAD: MODEL 39565-65, LOT# V459341030| EXPLANTED: