BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2609348 · Received June 11, 2012

    Report

    Report Number
    3004209178-2012-04291
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377845, LOT# V011532, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, LOT# V050384002, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COUPLING AND/OR COMMUNICATION ISSUES. THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT A ND NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE WAS LOOSE AND IT HAS MOVED AND WAS POKING HER. SHE HAS HAD ISSUES WITH HER INS POCKET MOVING TWO TIMES PREVIOUSLY, SAME LOCATION. THE PATIENT REPORTED THAT THE STIMULATION WAS TURNING OFF. THE PATIENT WAS HOSPITALIZED RECENTLY AND HAS HAD SEVERAL MEDICAL TESTS: DIAGNOSTIC ULTRASOUNDS, EEG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1