BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1928572 · Received November 16, 2010

    Report

    Report Number
    3004209178-2010-09659
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    May 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ONE DAY POST-IMPLANT, THE PATIENT REPORTED A LOSS OF STIMULATION IN HER LOWER BACK. THE PATIENT VISITED THEIR HEALTH CARE PROVIDER APPROXIMATELY ONE WEEK LATER, AND REPORTED "FEELS THE STIMULATION WITH SITTING, NOT STANDING." THE FOLLOWING STATEMENT WAS MADE BY THE HEALTH CARE PROVIDER "IF NEEDED WE NEED TO REVISE IT." ORAL MEDICATIONS WERE BEING GIVEN, INCLUDING PERCOCET, OTHERS WERE UNKNOWN. ANOTHER APPOINTMENT WITH THE HEALTH CARE PROVIDER HAD BEEN SCHEDULED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO 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 74 YR EXTENSION: MODEL 37082, LOT# NKB007359N| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE142981N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB004743V| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V248575| ACCESSORY: MODEL 37752, LOT# NKA136802N| LEAD: MODEL 3888, LOT# V337903| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V185950| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: