BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2802940 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09483
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER: PATIENT PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED UNK. PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWITCHING IN THE HANDS BEGAN (B)(6) 2012. TO CLARIFY, THE PATIENT WAS GIVEN THE STEROID PACK TO HELP WITH THE TWITCHING. ONCE THE PATIENT HAD FINISHED WITH THE STEROID PACK, THE PATIENT STARTED TO EXPERIENCED ¿UNBELIEVABLE PAINS IN THE BACK OF THE LEGS¿ UNLIKE ANYTHING HE FELT BEFORE AND COULD NOT LIE DOWN BECAUSE THE PAIN WOULD GO TO HIS HEAD. THIS WAS WHEN THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HE WAS GIVEN A STEROID SHOT AND SENT HOME. THE STEROID SHOT HELPED TO RELIEVE THE PAIN, BUT IT SOON RETURNED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE MAGNETIC RESONANCE IMAGING (MRI) SCAN TOOK PLACE THAT DECIDED THE PATIENT HAD ARACHNOIDITIS. THE PATIENT WAS TAKING CYMBALTA FOR THE UNCONTROLLABLE TWITCHING. IT WAS REPORTED THAT THE PATIENT¿S BLISTERS WERE THE SIZE OF A FINGERNAIL. THE PATIENT WOULD POP THEM AND THEY WOULD LEAVE SCARS ALL OVER THE PATIENT¿S HANDS. IT WAS ALSO REPORTED THAT WHEN THE PATIENT SLEPT HIS LEGS WOULD KICK, ARMS WOULD ¿FLY¿ AND HIS BODY WOULD SHAKE. THE NEUROLOGIST REQUESTED MRI SCANS OF THE ENTIRE SPINE AND BLOOD WORK TO BE DONE. ¿EVERYTHING CAME BACK GOOD.¿ THE MRI SCAN DID NOT SHOW ANYTHING AT ALL, SO IT WAS CONCLUDED THAT THE PATIENT¿S BODY MUST BE REJECTING THE PUMP. FOR NOW THE HEALTH CARE PROFESSIONAL WAS PLANNING ON KEEPING THE PUMP IN THE PATIENT AND REFILLING IT. THE PATIENT WAS LAST SEEN (B)(6) 2013, BUT THERE STILL WAS NO CONCRETE CONCLUSION AS TO WHAT WAS GOING ON. THE PATIENT WAS DOING ¿FINE¿ THOUGH.

    Description of Event or Problem · 1

    PATIENT REPORTS NEVER HAVING THERAPEUTIC EFFECT. THE PATIENT EXPERIENCED MYOCLONIC JERKS AND INCREASED PAIN. THE DOSAGE WAS BEING SLOWLY TITRATED. THE PATIENT EXPERIENCED TWITCHING IN THEIR HAND SINCE THE DOSAGE INCREASE. THE PATIENT REPORTED THE TWITCHING WAS MOSTLY WHEN LYING DOWN. THE PATIENT HAD BLISTERS THAT WOULD LAST FOR ABOUT A DAY ON HIS HANDS AND FOOT. PER PATIENT, THE PUMP WAS TAKING CARE OF ABOUT 50% OF HIS PAIN. THE PATIENT HAD PAIN IN THE BACK OF HIS LEGS AND WHEN LYING DOWN THE PAIN WOULD GO TO HIS HEAD. THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT WAS GIVEN A STEROID PACK AND AN ANTI-DEPRESSANT. AN MRI WAS DONE AND THE CONCLUSION WAS THAT THE PATIENT'S BODY WAS REJECTING THE PUMP. THE PATIENT'S BODY HAD REJECTED METAL IMPLANTS IN THE PAST. PER HCP, THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT DEVELOPED ARACHNOIDITIS. THE PATIENT WAS HOSPITALIZED FOR INTRACTABLE PAIN. THE PATIENT HAD APPARENTLY RECOVERED FROM ARACHNOIDITIS ACCORDING TO A NEW MRI BUT CONTINUED TO REPORT MYOCLONIC JERKS. THE PATIENT WAS EVALUATED BY A NEUROLOGIST WHO FOUND NO ETIOLOGY TO EXPLAIN THE MYOCLONIC JERKS. THE SITUATION WAS COMPLICATED BY SEVERE CHRONIC ANXIETY AND DEPRESSION AND THE PATIENT'S STRONG ATTACHMENT TO OXYCODONE. THE PATIENT WAS TAKING 240MG PER DAY. THE PATIENT CONSIDERED HAVING THE PUMP EXPLANTED. THE PUMP WAS DELIVERING BUPIVACAINE AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization