BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3230317 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11869
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    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 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005: PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3487A-33, LOT# J0337374V, IMPLANTED: (B)(6) 2003: PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT# J0337542V, IMPLANTED: (B)(6) 2003: PRODUCT TYPE LEAD; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003: PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003: PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS NOT WORKING. THE PATIENT STATED THAT SHE COULD NOT WALK ANYMORE AND COULD NOT FEEL HER LEGS SO SHE WAS NO LONGER USED THE SPINAL CORD STIMULATOR (SCS) BECAUSE SHE WOULD NOT BE ABLE TO TELL IF IT WAS ON OR OFF. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT HAD NOT USED THEIR SCS DEVICE IN ABOUT 10 YEARS. THE PATIENT STATED THAT BACK WHEN THEY HAD THE DEVICE IMPLANTED THEY ONLY HAD BACK PAIN BUT NOW HAD NEUROPATHY PAIN AND ¿FIGURED IF IT WASN¿T WORKING WHY USE IT¿. THE PATIENT ALSO NOTED THAT THEY HAD NUMBNESS IN THEIR LEGS AND COULD NOT TELL IF THE STIMULATION WAS ON OR OFF. THE PATIENT WAS NOW THINKING OF USING AN EXTERNAL STIMULATOR CALLED THE ¿REBUILDER¿ FOR THEIR NEUROPATHY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330022 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1