BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2955483 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02520
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    June 12, 2007
    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

    PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 389133, LOT# J0546581V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 389133, LOT# J0546581V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH LEG PAIN. THE REPORTER INDICATED THAT THE PATIENT HAD THE DEVICE PUT IN YEARS BACK WHICH THE REPORTER JUST FOUND 'HAD NEVER WORKED PROPERLY.' IT WAS NOTED THAT THE PATIENT HAD GOTTEN 'THE RUN AROUND' ON THE DEVICE SINCE IT WAS IMPLANTED. FIVE DAYS LATER, ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THAT BY 'DEVICE NEVER WORKED PROPERLY,' THE REPORTER MEANT THAT THE UNIT ITSELF WORKED BUT THE ELECTRODES 'HEALED IN THE WRONG POSITION.' AN X-RAY WAS DONE WHICH FOUND THAT THE 'ELECTRODES WERE IN THE WRONG POSITION.' THE CAUSE OF THE ISSUE WAS DETERMINED BUT NO INTERVENTIONS HAD BEEN TAKEN. THE REPORTER INDICATED THAT THE PATIENT WAS NOT RECEIVING THERAPY CURRENTLY, AND OTHER 'NERVE PROBLEMS' HAD DEVELOPED. AT 3 DAYS AFTER THE LAST REPORT, IT WAS FURTHER REPORTED THAT THE PATIENT WAS LAST SEEN AT HIS HEALTHCARE PROVIDER'S (HCP'S) OFFICE ON (B)(6) 2007. AT THAT TIME, TROUBLESHOOTING WAS DONE. IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE ADEQUATE RELIEF AND LEAD MIGRATION WAS SUSPECTED. AN APPOINTMENT WAS SCHEDULED WITH THE PATIENT'S HCP FOR 3 DAYS AFTER THE LAST APPOINTMENT TO DETERMINE NEXT STEPS, BUT THE PATIENT WAS A 'NO SHOW' FOR THAT APPOINTMENT. THE SUBSEQUENT APPOINTMENT WAS REPORTED TO HAVE BEEN CANCELLED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58308 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization