BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2974363 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02985
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 1, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 747220 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT#, SERIAL (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT DURING THE EXPLANT PROCEDURE THE EXTENSIONS WERE SEVERED AND LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS PREVIOUSLY EXPLANTED BY A PHYSICIAN ON AN UNKNOWN DATE. THAT INS WAS EXPLANTED "DUE TO ANOTHER PROCEDURE" BUT THE DETAILS OF THIS SITUATION WERE NOT AVAILABLE. IT WAS INDICATED THAT THE INS WAS DEPLETED WHEN IT WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE BATTERY WAS REMOVED AT THE TIME OF THE PATIENT'S DISCECTOMY SURGERY IN (B)(6) 2012. IT WAS REPORTED THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS AND THE PATIENT DESIRED THE EXPLANT. IT WAS ALSO REPORTED THE PATIENT HAD A REPLACEMENT SURGERY ON (B)(6) 2013 TO REPLACE THE BATTERY. IT WAS REPORTED THE BATTERY WAS SUCCESSFULLY IMPLANTED USING EXTENSION ADAPTORS AND THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND RECOVERED WITHOUT SEQUELAE. IT WAS ALSO REPORTED THE STIMULATION WAS RESTORED TO THE PATIENT'S SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78902 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