BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3800585 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08745
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    June 19, 2014
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 399930, LOT# V007489, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES (>4000 OHMS) WERE NOTED ON ELECTRODES #0-3 ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). THE CAUSE OF THE PRODUCT ISSUE WAS NOT DETERMINED AT THE TIME OF REPORT. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF TO THE LOW BACK AND RIGHT LEGS AREAS. DIAGNOSTICS AND TROUBLESHOOTING INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE PATIENT WAS TO SCHEDULE AN APPOINTMENT WITH THEIR DOCTOR FOR A REVISION CONSULTATION. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE - NO INJURY¿. FOLLOW UP INFORMATION RECEIVED 4 DAYS LATER REPORTED THAT THE DATE OF THE CONSULTATION WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT WAS RECEIVING PARTIAL THERAPY RESULTS WITH PROGRAMMING WITH #4-7 ELECTRODES AS IT COVERED MOST OF THEIR PAIN AREAS BUT NOT QUITE AS WELL AS PRIOR TO THE ¿FALLING¿ EVENT. THE PROGRAMMING AND IMPEDANCE RESULTS WERE SENT TO THE PATIENT¿S PHYSICIAN AT THEIR REQUEST. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PAIN IN THE PATIENT'S RIGHT HIP AND LEG WERE NOT BEING CONTROLLED. IT WAS REPORTED THE PATIENT HAD A REVISION AND REPLACEMENT ON (B)(6) 2014. IT WAS REPORTED THE LEAD, EXTENSION AND BATTERY WERE ALL REPLACED. IT WAS FURTHER REPORTED THE PATIENT HAD AN MRI AND NO MIGRATION HAD OCCURRED. IT WAS NOTED THAT DESPITE TWO REPROGRAMMINGS THE PAIN IS STILL NOT CONTROLLED. IT WAS FURTHER REPORTED THE ELECTRODE HAD SEPARATED. LASTLY IT WAS REPORTED THE EVENT DID NOT REQUIRE HOSPITALIZATION AND NO INJURY OCCURRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED ON 2014-(B)(6). IT WAS NOTED THAT WHEN THE LEFT LEAD WAS EXPLANTED IT WAS NOTICED THE ¿OUTER LAYER HAD COME OFF COMPLETELY¿. IT WAS DETERMINED THAT THIS WAS CAUSING THE HIGH IMPEDANCES. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS STILL AT 3.12V BUT IT WAS DECIDED TO REPLACE IT AS WELL. IT WAS REPORTED THE ONLY ISSUE WAS WITH THE LEAD. IT WAS FURTHER REPORTED THE PATIENT WAS DOING VERY WELL AFTER SURGERY AND RECEIVING GOOD COVERAGE. IT WAS NOTED THE HCP BELIEVED THAT DUE TO THE PATIENT BEING ¿VERY LARGE AND ACTIVE¿ THAT THE LEAD MAY HAVE STRETCHED BUT WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278975 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention