BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3800017 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08718
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT# J0217223V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT# J0214236V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT FLEW FROM NEW YORK TO FLORIDA THE OTHER DAY AND LAST NIGHT SHE NOTICED HER INS KEPT STARTING AND STOPPING. THE PATIENT HAS NOT TOUCHED ANYTHING NOR HAS SHE MADE ADJUSTMENTS WHEN THIS HAPPENED. RIGHT NOW THE PATIENT ¿DOESN¿T FEEL STIM AT ALL, BUT LAST NIGHT IT WAS LIKE SPUTTERING, IT WOULD START AND STOP, START AND STOP¿. THE PATIENT DID USE THE PATIENT PROGRAMMER LAST NIGHT TO VERIFY THAT THE STIMULATION WAS ON. THE PATIENT HAS 2 DIFFERENT PROGRAMS AND TRIED TO GO FROM ONE PROGRAM TO THE OTHER THINKING MAYBE THAT WOULD FIX THE PROBLEM AND IT WOULD WORK BUT STIMULATION WOULD JUST START AND STOP, START AND STOP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT FELT STIMULATION ON ONE SIDE, BUT NOT ON THE OTHER. IT WAS REPORTED INCREASING TO 10.5 V DID NOT RESOLVE THE ISSUE. IT WAS NOTED THE PATIENT GOT SOME COVERAGE ON ELECTRODES FOUR THROUGH SIX. IT WAS REPORTED THE PATIENT¿S DEVICE HAD IMPEDANCES RANGING FROM 809 TO 5 ,379 OHMS. IT WAS REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF 2014-(B)(6) WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279413 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR