BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3071268 · Received April 22, 2013

    Report

    Report Number
    6000032-2013-00100
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 4, 2013
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# L98558, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: LEAD: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT ALONG WITH ACUTE PAIN AND A BURNING SENSATION. IT WAS ALSO REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "DIED" AROUND (B)(6) 2013 AND THE PATIENT STILL RECEIVED SHOCKS THAT MADE HER MUSCLES "TWIST LIKE A PRETZEL" AND HER BODY WAS JERKING. THE PATIENT ALSO STATED THEY EXPERIENCED A STABBING PAIN IN THEIR BACK WHERE THEIR LEAD WAS LOCATED. IT WAS ALSO REPORTED THIS WAS A NEW PAIN AND DESCRIBED AS SOMEONE "STABBING HER WITH A PEN." THERE WERE NO REPORTED FALLS OR TRAUMA. IT WAS NOTED ALL 3 GREEN LIGHTS CAME ON WHEN THE PATIENT'S PROGRAMMER TURNED ON, BUT THE TOP YELLOW LIGHT ON THE RIGHT SIDE OF THE PROGRAMMER CAME ON WHEN IT WAS TURNED OFF, INDICATING A "DEAD" INS. REPORTEDLY, NOTHING HAPPENED WHEN THE PATIENT TRIED TO TURN ON THE INS. IT WAS LATER REPORTED ON (B)(6) 2013 THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) TESTED BY A MANUFACTURER REPRESENTATIVE 2.5 YEARS PRIOR TO REPORT AND THERE WAS ONLY ONE THIRD OF THE INS LEFT. IT WAS ALSO STATED THE BATTERY DIED BUT THE PATIENT DID NOT GIVE A DATE. IT WAS ALSO STATED THE INS WAS STILL "SENDING ELECTRICAL CURRENT AND IT TURNS HER INTO A PRETZEL AND SHE WAS SHAKING AND COULDN'T SLEEP FOR MORE THAN 1-2 HOURS A NIGHT." IT WAS ALSO NOTED THE PATIENT STATED "THE DEVICE GAVE HER LIFE BACK AND SHE WANTED A NEW BATTERY PUT IN." (**OMITTED INFO FROM PE 700286152 - IMPLANT REVISION**).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172670 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR