BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4232911 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21092
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HAVING SPASMS. IT WAS NOTED AROUND (B)(6) 2014 (THE LAST TIME THEY WENT FOR A FILL) THEY DISCOVERED THE PUMP WAS DRY. EVER SINCE THEN THE PATIENT HAD BEEN EXPERIENCING INTERMITTENT MYOCLONIC TYPE JERKS, ALMOST SEIZURE TYPE ACTIVITY. THEY THOUGHT IT WAS EPILEPSY AND A VIDEO ELECTROENCEPHALOGRAM (EEG) WAS PERFORMED, WHICH WAS NEGATIVE. THE PATIENT¿S FAMILY WAS CONCERNED THAT THE PUMP WAS MALFUNCTIONING. IT WAS FURTHER REPORTED THEY DID NOT HEAR THE ALARM SO THEY WERE NOT AWARE THE PUMP WAS DRY. IT WAS NOTED THE HEALTHCARE PROVIDER (HCP) SCHEDULED THE FILL LATE AND WHEN THEY WENT TO REMOVE THE DRUG IN THE PUMP IT WAS EMPTY. THE PATIENT HAD BEEN FEELING POORLY AND HAVING THESE EPISODES FOR A COUPLE OF DAYS BEFORE HE FILLED IT. A ¿PUMP ¿O¿ GRAM¿ WAS PERFORMED AND SHOWED THAT THE CATHETER WAS OK. THE PATIENT WENT FIFTEEN PLUS YEARS WITH EVERYTHING WORKING FINE AND SUDDENLY NOW SHE WAS HAVING THESE SEIZURES, WHICH THEY COULD NOT EXPLAIN. WHEN SHE HAD ¿THESE SPELLS¿ SHE STARTED SHAKING, HER EYES STARTED WATERING, NOSE GETS STUFFY, SHE TURNED RED, AND ¿SOMETIMES SHE SMELLS FUNNY.¿ THE PATIENT WAS SHAKING LIKE THIS SEVERAL TIMES A DAY. IT WAS ALSO REPORTED THE PATIENT WAS ALLERGIC TO MORPHINE, WHICH WAS WHY SHE USED DILAUDID. THE PATIENT USED TO DOUBLE THE DOSE, BUT HAD BEEN CUTTING DOWN IN THE ¿PAST 3, 4, 5, YEARS.¿ NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A DYE STUDY FOR COMPLAINTS OF INCREASED PAIN AND NEW JERKING MOVEMENTS THAT HAD DEVELOPED AND WERE UNEXPLAINED SINCE APPROXIMATELY (B)(6) 2014. A DYE STUDY WAS PERFORMED AND THERE WAS NO OBVIOUS ISSUE NOTED AT THE STUDY AND THE CATHETER ASPIRATED WELL. THE PATIENT MISSED THE LAST REFILL DUE TO HEALTH ISSUES INVOLVING HER UNDERGOING RADIATION FOR BREAST CANCER AND THE PATIENT¿S PUMP WAS DRY. THE PATIENT WAS REFILLED BY THE MANAGING DOCTOR ON (B)(6) (B)(6) 2014. NO WITHDRAWAL SYMPTOMS WERE REPORTED JUST INCREASING PAIN AND NEW JERKING MOVEMENTS. THE PATIENT ALSO EXPERIENCED LESS THAN 50% THERAPY RELIEF AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ IT WAS NOTED THE PATIENT REQUIRED HOSPITALIZATION AND THE LOGS WERE ALSO CHECKED. IT WAS NOTED WHEN THE PUMP WAS INTERROGATED ON (B)(6) 2014 THE LOW RESERVOIR ALARM WAS NOTED IN THE LOGS, BUT AN EMPTY ALARM WAS NOT NOTED. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE. THE CAUSE OF THE ISSUE, FURTHER INTERVENTIONS, AND OUTCOME WERE NOT REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3007566237-2014-03218 [IT WAS REPORTED THAT THE PATIENT MISSED A REFILL AND THE PUMP WENT EMPTY. THE PATIENT HAD WITHDRAWAL SYMPTOMS AND WAS IN THE HOSPITAL. IT WAS REPORTED THAT THE PUMP WAS ONLY EMPTY FOR ONE DAY AND THE PUMP WAS REFILLED ON (B)(6) 2014. THE PUMP DELIVERED AN UNKNOWN DRUG AT THE TIME OF THE EVENT]. ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER REPORT NUMBER #3004209178-2014-21092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712865 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization