BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3790082 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08489
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-45, LOT# V234613, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N199228, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-45, LOT# V234613, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT# N199228, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3487A-45, LOT# V234613, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT COULD NOT GET HIS STIMULATION TO TURN BACK ON. THE ¿CALL YOUR DOCTOR¿ ICON DISPLAYED ON THE RECHARGER. THE END OF SERVICE (EOS) MESSAGE WAS ALSO SEEN. THIS WAS ABOUT 2 WEEKS AGO. THE INS WAS CHARGED UP IT JUST WOULD NOT TURN ON. THE NEXT DAY A PROBLEM WITH THE PATIENT PROGRAMMER (PP) WAS REPORTED. THE PATIENT AS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. A COMMUNICATION PROBLEM WAS REPORTED WITH THE RECHARGER. AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT LAST RECHARGED AND FELT STIMULATION A FEW MONTHS AGO. THE PATIENT STARTED TO HAVE TROUBLE RECHARGING 2 MONTHS AGO. THE RECHARGER AND PP COULD NOT CONNECT WITH THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268705 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 00054 YR