BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1712282 · Received May 28, 2010

    Report

    Report Number
    3004209178-2010-04278
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Report Date
    April 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE PATIENT ONLY FELT STIMULATION WHEN HE WAS ARCHING HIS BACK. THE PATIENT REPORTED THAT SINCE IMPLANT THE DEVICE HAD NOT WORKED AND NOT PROVIDED ANY THERAPEUTIC BENEFIT, THE PATIENT WANTED TO HAVE THE DEVICE EXPLANTED. IT WAS NOTED THAT NO IMAGING HAS BEEN DONE TO LOOK AT THE LOCATION OF THE LEAD. TWO MONTHS LATER, THE PATIENT CONTINUED TO ONLY FEEL THE STIMULATION WHEN HE ARCHED HIS BACK. IT WAS ALSO NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS CAUSING THE PATIENT PAIN. THE PATIENT CONTINUED TO WANT THE DEVICE EXPLANTED. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. FOUR MONTHS AFTER THE SECOND REPORT, IT WAS REPORTED THAT THE DEVICE NEVER HELD A CHARGE. IT WAS ALSO NOTED THAT THE PATIENT HAD TO LIE ON THE FLOOR WITH AN ARCH IN HIS BACK TO FEEL ANY STIMULATION. OTHERWISE THE PATIENT DIDN'T USE THE DEVICE. THE DEVICE WAS SCHEDULED TO BE REMOVED (B) (6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 37083, LOT# NKC011466N| PROGRAMMER: MODEL 37742, LOT# NJD043394N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V029383| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC011459N