BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2770253 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08829
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: EXTENSION: PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3587A, LOT# LA1830, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: LEAD: PRODUCT ID 3487A, LOT# J0104259V, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING SHOCKING OR JOLTING SENSATIONS AND HAD HER SPINAL CORD STIMULATOR (SCS) REMOVED. IT WAS REPORTED TO BE SHOCKING THE PATIENT ANYTIME SHE WAS AROUND APPLIANCES WITH A POWER SURGE, FOR EXAMPLE, WHEN THE LIGHTS WOULD COME ON OR AROUND POWER LINES. PATIENT ALSO EXPERIENCED SHOCKING THAT WOULD MAKE HER "JUMP OUT OF HER CHAIR" ANY TIME THE DOCTOR CHANGED HER SETTINGS. PATIENT EXPERIENCED RELIEF, BUT NOT ENOUGH TO TOLERATE THE SHOCKING. PATIENT'S SCS WAS REPLACED WITH A PUMP AND THE ISSUES ARE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1