BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3112282 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07640
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT TURNED OFF HER IMPLANTABLE NEUROSTIMULATOR (INS) A YEAR AGO BECAUSE IT "WAS NOT WORKING." IT WAS REPORTED THE PATIENT'S PAIN WAS DOWN BOTH HER LEGS AND SHE WAS HAVING TROUBLE CONTROLLING HER BLADDER AS WELL. THE PATIENT HAD AN APPOINTMENT WITH HER HEALTHCARE PROVIDER (HCP) THE FOLLOWING DAY TO TALK ABOUT HAVING HER INS REMOVED BUT THE PATIENT WANTED TO TRY USING HER DEVICE AGAIN BEFORE SHE HAD IT REMOVED. IT WAS NOTED THE PATIENT HAD NOT CHARGED IN OVER A YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213402 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1