BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3231311 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11888
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7435 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 89033 LOT# J0436978V, IMPLANTED: 2004 (B)(6), EXPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 748925 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 748925 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID 389033 LOT# J0436978V, IMPLANTED: 2004 (B)(6), EXPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO HAVE THEIR IMPLANTABLE NEUROSTIMULATOR REPLACED ON 2009 (B)(6) BECAUSE "IT DIDN¿T WORK." IT WAS NOTED THAT THE HEALTH CARE PROVIDER (HCP) TOLD THE PATIENT THAT IT "WOULD NOT CONNECT TO WHERE IT WAS ON HIS SCAR TISSUE ON HIS BACK." IT WAS NOTED THAT THE PATIENT STATED HE HAD AN ENORMOUS AMOUNT OF SCAR TISSUE ON BOTH SIDES. IT WAS NOTED THAT THE HCP HAD TO PUT IN A "WHOLE NEW EVERYTHING." IT WAS NOTED THAT AFTERWARD THE THERAPY WORKED GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331596 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention