BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 5104523 · Received September 25, 2015

    Report

    Report Number
    3004209178-2015-18738
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    September 1, 2015
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# J0504281V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED THAT IMPEDANCES WERE TESTED AT 5V, 450USEC, AND 30HZ: 01 2017 02 2017 03 >4K 04 3379 05 2528 06 3379 07 2017 12 2528 13 >4K 14 >4K 15 3379 16 >4K 17 3379 23 ??? 24 3379 25 3379 26 ??? 27 2528 34 >4K 35 >4K 36 >4K 37 >4K 45 2017 46 3379 47 2528 56 2017 57 2017 67 2017. THERAPY IMPEDANCES SHOWED GREATER THAN 4000 ON PROGRAM 1 ON CONTACTS 123, AND 1655 ON PROGRAM TWO CONTACTS 567. THE PATIENT HAD FALLS SINCE LOSING STIMULATION BUT NOT BEFORE. THERE WERE NO FALLS OR TRAUMA RELATED TO THIS ISSUE. THE MANUFACTURER REPRESENTATIVE (REP) INTERROGATED THE DEVICE AND PROGRAM 1 WAS AT .2V AND PROGRAM 2 WAS AT 1.2V. THEY TURNED UP PROGRAM 2 UP TO 8V AND THE PATIENT STILL COULD NOT FEEL STIMULATION. IT WAS NOTED THAT DOCTOR WOULD NOT REVISE THE SYSTEM AS THE PATIENT ALREADY HAD A PUMP AND WAS IN A WHEELCHAIR. THE PATIENT WAS NOT A GOOD CANDIDATE FOR REVISION CONSIDERING THEIR SITUATION. THE PATIENT'S VOLTAGE WAS HEALTHY AT 2.64V AND THE INS WAS SOMEWHERE BETWEEN 35-70% USED. THERE WAS A LOSS OF STIMULATION SENSATION. DURING THE ELECTRODE IMPEDANCE TEST THE PATIENT FELT STIMULATION INTERMITTENTLY. ON (B)(6) 2015 THE REP INDICATED THEY WERE ABLE TO USE TWO ELECTRODES AND PROGRAM AROUND IT OTHERWISE THERE WAS NO PLAN TO REPLACE ANY LEADS AND THE PATIENT HAD A PAIN PUMP. OTHER RELEVANT MEDICAL HISTORY INCLUDES SPINAL PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636511 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR