BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2892104 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00006
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    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

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID NEU_ UNKNOWN_EXT, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THE REPORTER STATED THAT THE DEVICE WAS BEING REPLACED AND IT WAS AT EOL (END OF LIFE), WHICH WAS WHY THE PATIENT DIDN'T HAVE STIMULATION. IT WAS NOTED THAT ELECTRODES 4-7 ALL HAD IMPEDANCES GREATER THAN 4000, BUT IT WAS UNCLEAR IF THERE WAS A LEAD THERE. IN THE PAST THE PATIENT HAD ONLY BEEN PROGRAMMED USING ELECTRODES 0-3. USING ELECTRODES 0-3, THE PATIENT WAS UNABLE TO GET STIMULATION. VARIOUS ELECTRODE COMBINATIONS WERE TRIED, AND THERE WAS STILL NO STIMULATION RESPONSE. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HIGH IMPEDANCES, A LEAD/EXTENSION ISSUE OF A BREAK OR FRACTURE, AND LOSS OF STIMULATION. THE REPORTER STATED THAT THE PATIENT THOUGH HIS DEVICE WAS DEAD OVER A YEAR AGO. THE PATIENT WAS SCHEDULED FOR AN IMPLANTABLE NEUROSTIMULATOR EXCHANGE AND THE SURGEON DISCONNECTED THE LEAD FROM THE EXTENSION AND DID AN INTEROPERATIVE LEAD TEST WHICH INDICATED ELECTRODE IMPEDANCE GREATER THAN 4000 ON ALL ELECTRODES. IT WAS REPORTED THAT THE SURGEON EXPLANTED THE IMPLANTABLE NEUROSTIMULATOR AND EXTENSION AND LEFT THE LEAD IN PLACE. THE REPORTER STATED THAT THE SURGEON ADVISED THAT A LEAD REVISION BE PERFORMED AT A LATER DATE WITH POSSIBLE RETRIAL DUE TO THE EXISTING LEAD BEING LOWER THAN EXPECTED FOR THE PATIENT'S DESIRED AREA OF THERAPY COVERAGE. IT WAS NOTED THAT THERE WAS NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REFERRED BACK TO HIS PAIN PHYSICIAN AND RE-TRIALED. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION ON (B)(6) 2013. NINE DAYS LATER, IT WAS REPORTED THAT A PATIENT HAD A NEW SURGICAL PADDLE LEAD PLACED BASED ON THE TRIAL PROCEDURE. IT WAS NOTED THAT THE CURRENT LEAD WAS NOT REVISED AND A NEW LEAD WAS PLACED IN AN ALTERNATE LOCATION HIGHER UP THE PATIENT'S SPINE. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851 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