BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2821489 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09958
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A POWER ON RESET (POR). IT WAS NOTED THAT THE PATIENT'S SYMPTOMS RETURNED. THE PATIENT REPORTEDLY WAS UNCERTAIN ABOUT THE LAST TIME THE DEVICE WAS CHARGED, AND WAS GETTING A "REPOSITION ANTENNA" SCREEN. IT WAS INDICATED THAT THE PATIENT TRIED REPOSITIONING THE ANTENNA BUT STILL GOT THE "REPOSITION ANTENNA" SCREEN. THE PATIENT REPORTED A "#58 THEN ALL 8 COUPLING BARS AND IMPLANTABLE NEUROSTIMULATOR (INS) CHARGING". ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT # 3004209178-2012-09957.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT FELT THEIR STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE PAST 3 MONTHS. IN ADDITION, THE PATIENT HAD NOT CHARGED THEIR INS FOR THE SAME TIME FRAME. THE INS WAS SUSPECTED TO BE IN AN OVERDISCHARGE CONDITION DUE TO THE PATIENT NOT RECHARGING THE DEVICE. THE PATIENT WAS INSTRUCTED TO USE THE ANTENNA LOCATOR FEATURE OF THE RECHARGER (READING OF 36 REPORTED) TWICE BUT WAS STILL UNABLE TO CHARGE THEIR DEVICE. IT WAS NOTED THAT THE PATIENT HAD MULTIPLE INS SYSTEMS AND THE OVERDISCHARGE CONDITION WAS PRESENT ON ALL OF THEM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    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