BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5068582 · Received September 10, 2015

    Report

    Report Number
    3004209178-2015-17739
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 14, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 399960, LOT# V041368, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 399960, LOT# V041368, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE PATIENT WAS IN OVERDISCHARGE. THE OVERDISCHARGE HAD NOT BEEN CLEARED. THE INDICATIONS FOR USE WERE CHRONIC LOW BACK PAIN, CERVICAL RADICULOPATHY, DEGENERATIVE DISC DISEASE/HERNIATED DISC PAIN, AND RADICULAR PAIN SYNDROME (RADICULOPATHIES). ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTED THE INS WAS RESCUED FROM OVERDISCHARGE AND THE PATIENT WAS ABLE TO GET IT FULLY CHARGED UP. THE POWER ON RESET (POR) WAS CLEARED AND THE INS WAS REPROGRAMMED TO BETTER HELP THE PATIENT'S PAIN. THE REP CHECKED THE IMPEDANCES AND ELECTRODES #11 AND #15 WERE OVER 10K AND NOT USABLE. NEITHER ELECTRODE WAS NEEDED OR USED IN THE FINAL PROGRAMMING OPTIONS AND THE PATIENT'S PAIN WAS WELL COVERED. THE OTHER INS WAS ALSO IN OVERDISCHARGE AND WAS NON-RESPONSIVE TO ATTEMPTS TO REAWAKEN IT. THE SURVIVING INS COVERED THE PATIENT'S WORST PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. PLEASE SEE MANUFACTURER REPORT #3004209178-2015-17737 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600050 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 00064 YR