BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4804949 · Received May 29, 2015

    Report

    Report Number
    3004209178-2015-09904
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    May 13, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 399930, LOT# V013446, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REMOVAL OF A MALFUNCTIONING EPIDURAL LEAD AND INSERTION OF ANOTHER LEAD FROM THE MANUFACTURER THROUGH A NEW SEPARATE LAMINECTOMY WITH REAL TIME FLUOROSCOPY ON (B)(6) 2008. THE PATIENT HAD THE IMPLANTATION OF THE STIMULATOR ON (B)(6) 2007. FURTHER INFORMATION REGARDING THIS MALFUNCTIONING LEAD AND PATIENT OUTCOME HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348885 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention