BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 5070490 · Received September 11, 2015

    Report

    Report Number
    3004209178-2015-17787
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    August 19, 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 7425, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997, EXPLANTED: (B)(6) 2002, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3998, LOT# LA4177, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT, IMPLANTED FOR FAILED BACK SURGERY SYNDROME AND FAILED BACK SYNDROME - OTHER, REPORTED THAT THE DEVICE HAS NEVER REALLY COVERED THEIR PAIN AND THEY HAD A LOSS OF THERAPY. THE PATIENT HAS TO STAND STRAIGHT UP TO FEEL STIMULATION BUT IF THEY SLOUCH THE STIMULATION GOES AWAY. THEN THEY HAVE TO TURN STIMULATION UP BUT WHEN THEY LIE DOWN IT SHOCKS THEM BECAUSE THEY FORGET TO TURN THE STIMULATION DOWN. THE PATIENT HAS NOT TAKEN ANY STEPS OR ACTION TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF THERE WAS A SUDDEN OR GRADUAL CHANGE IN THERAPY/SYMPTOMS. IT WAS FURTHER REPORTED ON (B)(6) 2015 THAT IT WAS NOT KNOWN WHEN END-OF-LIFE (EOL) ACTUALLY OCCURRED BUT THE INS WAS SHOWING EOL ON THE CLINICIAN PROGRAMMER. THE PATIENT WAS GETTING GOOD THERAPY PRIOR TO THE EOL. THE LAST RESET OF COUNTERS WAS ON (B)(6) 2015 PER THE CLINICIAN PROGRAMMER. IT WAS UNKNOWN IF THE PATIENT HAD ANY FALLS OR TRAUMA LATELY. THE IMPEDANCE VALUES WERE AS FOLLOWS (IN OHMS) WITH THE FIRST NUMBER TAKEN AT DEFAULT SETTINGS AND THE SECOND NUMBER AT 2 VOLTS, 450 US (I.E. XX = DEFAULT, 2V<(>&<)>450US): 01 = 1537, ?? 02 = ??, >4000 03 = ??, >4000 04 = >4000, >4000 05 = > 4000, >4000 06 = >4000, >4000 07 = >4000, >4000 12 = 1537, 2212 13 = 1537, 2212 14 > 4000, >4000 15 = ?? , ?? 16 = 1537, 2212 17 = >4000, >4000 23 = 749, 716 24 = ??, >4000 25 = ??, ?? 26 = 761, ?? 27 = 1537, 2212 34 = ?? , >4000 35 = ??, 1091 36 = 761, 866 37 = 1537,2212. IT WAS REVIEWED THAT #0 WOULD APPEAR TO BE CLEAR OPEN, WITH IMPEDANCES OF GREATER THAN 4000 OHMS, AND THE OTHERS LOOKED OKAY. NO OUTCOME OR INTERVENTION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603500 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR