BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2983558 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03178
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7496-25, SERIAL # (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE EXTENSION; PRODUCT ID 7434A, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7425, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 74001, LOT # N240158, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 3888-28, IMPLANTED: (B)(6) 1992, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3586, SERIAL # (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT AND IT WAS DETERMINED THAT THE INTERMITTENT STIMULATION WAS DUE THE FACT THAT THE PATIENT DID NOT HAVE THE PROGRAMMER COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) TO ADJUST THE STIMULATION. THE PATIENT WAS PROVIDED WITH A NEW PROGRAMMER AND THE STIMULATION WAS INCREASED "UP A LITTLE" WHICH COMPLETELY SOLVED THE INTERMITTENT STIMULATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION IS INTERMITTENT. IT WAS STATED THAT THE PATIENT'S STIMULATION TURNS OFF AND BACK ON. IT WAS NOTED THAT PATIENT WILL MEET WITH A MANUFACTURER REPRESENTATIVE TO DISCUSS POSSIBLE ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION CLARIFIED THAT THE PATIENT ALSO LOST THE RECHARGER UNIT FOR THIS INS AND WAS GIVEN A NEW ONE. THE INS WAS BROUGHT OUT OF AN OVERDISCHARGE CONDITION AND WAS REPORTED AS WORKING FINE AS WAS THE NEW RECHARGER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85755 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