BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3111087 · Received May 14, 2013

    Report

    Report Number
    6000032-2013-00122
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-33, LOT # J0327021V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # J0327021V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PAIN ISSUES AND THEIR PAIN MANAGEMENT HAD BEEN A PROBLEM. IT WAS ALSO REPORTED THE HEALTHCARE PROVIDER HAD NOT USED THE PATIENT PROGRAMMER ON THE PATIENT'S DEVICE YET TO CHECK THE IMPLANTABLE NEUROSTIMULATOR (INS) AND SEE IF IT WAS WORKING PROPERLY. IT WAS NOTED THE PATIENT HAD PAIN ISSUES ON AND OFF SINCE THEY WERE FIRST ADMITTED TO A NURSING HOME ON (B)(6) 2012. IT WAS ALSO STATED THE PATIENT HAD BEEN ADMITTED AGAIN ON (B)(6) 2013 AND THEIR PAIN HAD "WORSENED LATELY." THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTHCARE PROVIDER. FOUR DAYS LATER, IT WAS REPORTED THE HEALTHCARE PROVIDER WAS NOT ABLE TO VIEW ANY STATUS LIGHTS ON THE PATIENT PROGRAMMER. THE HEALTHCARE PROVIDER THEN REPLACED THE BATTERY IN THE PROGRAMMER AND SWITCHED THE SETTING TO AMPLITUDE AND WAS THEN REPORTEDLY ABLE TO VIEW THE LIGHTS ON THE PROGRAMMER AND TURNED THE PATIENT'S STIMULATION ON. IT WAS STATED THE PATIENT WAS IN PAIN AT THE TIME OF REPORT AND THEY COULD NOT CONFIRM IF THEY FELT STIMULATION. IT WAS ALSO NOTED THE PATIENT WAS IN A WHEELCHAIR AND DID NOT HAVE THE COGNITIVE ABILITY TO KNOW IF THE INS WAS TURNED ON. THE PATIENT WAS REPORTED TO HAVE BEEN ON HEAVY PAIN MEDICATION AND "OUT OF IT." THE HEALTHCARE PROVIDER DID NOT KNOW IF THE INS WAS WORKING AND WAS ADVISED TO CALL BACK WHEN THE PATIENT WAS MORE ALERT TO GET PATIENT FEEDBACK. ADDITIONAL INFORMATION STATED THE PATIENT'S PHYSICIAN WAS "UNABLE TO ASSESS" WHICH DEVICE CAUSED THE EVENT. IT WAS FURTHER STATED THAT IT WAS "UNKNOWN" WHETHER THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LEAD/EXTENSION WAS THE ISSUE. IT WAS NOTED THE PATIENT WAS "UNABLE TO IDENTIFY THE IMPULSE." IT WAS REPORTED THE PATIENT "HAD A DECLINE IN HEALTH AND COGNITION" "DUE TO THE PROGRAMMING OR THE PROGRAMMER" AND WOULD BE REASSESSED WHEN THE PATIENT'S "COGNITION INCREASED." IT WAS ADDITIONALLY REPORTED THE PATIENT HAD "INCREASED PAIN IN THEIR LEFT LEG TO HIP." THE PATIENT'S OUTCOME WAS REPORTED AS "SERIOUS INJURY/ILLNESS - ONGOING" AND IT WAS NOTED THE PATIENT HAD "BILATERAL DVT" (DEEP VEIN THROMBOSIS). IT WAS FURTHER NOTED "THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT." A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213377 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization