BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3230204 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11860
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# L49004, IMPLANTED: (B)(6) 1998, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED IN 2007 DUE TO AN INFECTION. IT WAS NOTED THAT THE LEADS REMAINED IMPLANTED. IT WAS FURTHER NOTED THE BATTERY WAS IMPLANTED IN THE STOMACH BUT ¿WHATEVER THEY IMPLANTED IN THE BACK WAS STILL THERE.¿ IT WAS UNKNOWN WHETHER THE PATIENT WAS REFERRING TO A DEVICE OR LEAD IN THE BACK. IT WAS NOTED THAT X-RAYS WOULD BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329787 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention