BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3003930 · Received March 14, 2013

    Report

    Report Number
    3004209178-2013-03702
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748940 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748940 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3998 LOT# J0444256V, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES GREATER THAN 5000 OHMS WERE MEASURED ON THE EXTENSIONS. THE LEAD WAS HOWEVER, FINE. THE EXTENSIONS AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE CONSEQUENTLY REPLACED. THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107413 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention