BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2547974 · Received April 25, 2012

    Report

    Report Number
    3004209178-2012-02665
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Report Date
    April 2, 2012
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3998, LOT# V110881, IMPLANTED: 2009 (B)(6), RECHARGER: MODEL 37752, SERIAL# (B)(4). PROGRAMMER: MODEL 37743, SERIAL# (B)(4), EXTENSION: MODEL 3708260, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE STIMULATION WAS ON IT WAS "NOT WORKING ANYMORE." THE DEVICE POCKET SITE CAUSED THE PATIENT DISCOMFORT AND THE PATIENT BELIEVED IT WAS AFFECTING HIS ABILITY TO VOID OR HAVE A BOWEL MOVEMENT. THE PATIENT WANTED THE DEVICE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER REPRESENTATIVE OR HCP AND HIS CONCERNS WERE RESOLVED. THE PATIENT DID NOT REMEMBER WHEN THE APPOINTMENT HAD TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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