BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3211113 · Received July 8, 2013

    Report

    Report Number
    6000032-2013-00165
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 13, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3998, LOT# L94479, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001,PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THIS THING WAS KILLING¿ THE PATIENT. IT WAS FURTHER REPORTED THAT THREE TO FOUR YEARS PRIOR TO THIS REPORT ¿SOMETHING WAS WRONG¿ WITH THE DEVICE. AT THAT TIME, THE MANUFACTURING REPRESENTATIVE WAS ABLE TO TURN THE DEVICE ON. SINCE THAT TIME THE PATIENT HAD BEEN UNABLE ¿GET IT ON OR OFF.¿ IT WAS NOTED FOR ABOUT FOUR OR FIVE YEARS PRIOR TO REPORT THE PATIENT HAD BACK PAIN AND IT WAS ¿GETTING WORSE.¿ THE PAIN WAS LIKE A TOOTHACHE AND HURT ¿ALL NIGHT LONG.¿ IT WAS NOTED THE PATIENT HAD LOST WEIGHT ABOUT FIVE MONTHS PRIOR TO THIS REPORT. THE PATIENT HAD GONE FROM (B)(6) POUNDS. THE PATIENT REPORTED THE POSSIBILITY OF ¿METAL IN THE BLOODSTREAM.¿ THE CAUSE OF THE WEIGHT LOSS WAS UNKNOWN BUT THAT IT COULD BE RELATED TO THE DEVICE. IT WAS NOTED THAT THE PATIENT ¿EATS LIKE A HORSE.¿ THE PATIENT FELT THROBBING FOR ABOUT ONE MONTH PRIOR TO THIS REPORT. IT WAS NOTED THAT THE PATIENT FELT STIMULATION. IT WAS NOTED THE PATIENT HAD PUT IN NEW BATTERIES IN THE PATIENT PROGRAMMER AND THREE GREEN LIGHTS WERE ON. THE PATIENT WAS GOING TO HAVE THE DEVICE REMOVED. THERE WERE ¿A COUPLE¿ OF OTHER PEOPLE WHO HAD THE SAME PROBLEM. IT WAS NOTED THAT ¿THEY¿ STATED IT WAS RELATED TO THE DEVICE. THE PATIENT DID NOT CLARIFY WHO ¿THEY¿ WERE. IT WAS FURTHER REPORTED THAT SIX MONTHS TO THREE YEARS PRIOR TO THIS REPORT THE PATIENT¿S BACK BEGAN TO HURT AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS NOTED THAT THE PATIENT HAD INCREASED BASELINE PAIN IN THE LOW BACK. IT WAS FURTHER NOTED THE PATIENT COULD NOT ¿KEEP GOING WITH THIS PAIN.¿ IT WAS NOTED THAT THE INS ¿WON¿T WORK, IT QUIT.¿ THREE TO FOUR YEARS PRIOR TO THIS REPORT THE DEVICE WAS CHECKED AND IT WAS DIFFICULT TO TURN ON THE DEVICE. IT WAS NOTED THAT IF THE DEVICE WAS ¿MESSED WITH LONG ENOUGH¿ IT MIGHT TURN ON BUT THEN IT COULD NOT BE SHUT OFF. IT WAS NOTED THAT ¿LONG ENOUGH¿ WAS 30 TO 40 MINUTES. IT WAS NOTED THAT WHEN THE DEVICE WAS ON IT EASED THE PAIN ¿SOME¿ BUT DID NOT STOP THE ¿TINGLING¿ PAIN. IT WAS FURTHER NOTED THAT THE INS WORKED INITIALLY AND ¿SERVED ITS PURPOSE.¿ IT WAS FURTHER NOTED THAT ¿THIS THING HAS TO COME OUT OR SOMETHING.¿ IT WAS NOTED THAT IT WAS NOT ¿BOTHERING¿ THE PATIENT TO HAVE THE INS IMPLANTED AND DID NOT WANT IT REMOVED IF IT WAS TOO DANGEROUS. IT WAS NOTED THAT THE PATIENT COULD ¿HARDLY¿ WALK BECAUSE THE LEFT LEG WAS BECOMING NUMB. THE LEG GAVE OUT SO THE PATIENT ¿WALKS AND FALLS, WALKS AND FALLS.¿ THE PATIENT NOTED ¿I¿M LOSING THE USE OF THIS LEFT LEG.¿ IT WAS NOTED THE PATIENT HAD THREE BACK OPERATIONS. IT WAS FURTHER NOTED THAT IT COULD BE DIFFICULT TO REMOVE THE INS DUE TO SCAR TISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED TO SPEAK WITH A HEALTHCARE PROFESSIONAL (HCP) ABOUT POTENTIAL INS REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311251 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR