BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3843874 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09980
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8711, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE DAY FOLLOWING THE PATIENT¿S EXPECTED END OF LIFE PUMP REPLACEMENT SURGERY AT WHICH TIME THE CATHETER HAD NO FLOW UPON DISCONNECTION AND BROKE (REFER TO MANUFACTURER REPORT # 3004209178-2014-09971 FOR THAT EVENT), IT WAS REPORTED THE PATIENT EXPERIENCED RESPIRATORY DEPRESSION AND AN OVERDOSE. THE HEALTH CARE PROVIDER (HCP) ASKED ABOUT PROGRAMMING A PUMP TO STOPPED PUMP MODE. LATER THAT SAME DAY, IT WAS FURTHER REPORTED THAT AT APPROXIMATELY 1900 ON (B)(6) 2014 THE PATIENT STARTED DEMONSTRATING RESPIRATORY DEPRESSION SO THE PUMP WAS PROGRAMED AT THAT TIME TO 100MCG/DAY OF BACLOFEN. AT APPROXIMATELY MIDNIGHT, THE PATIENT CONTINUED DEMONSTRATING RESPIRATORY DEPRESSION AND HYPOTENSION SO THE PUMP WAS STOPPED. ALL ORAL ANTISPASMODICS WERE HELD. AT APPROXIMATELY 10:30AM ON (B)(6) 2014, THE PUMP HAD GABLOFEN 2000MCG/ML CONCENTRATION IN THE RESERVOIR SO IT WAS RESTARTED AT THE LOWEST THERAPEUTIC RATE OF 96MCG/DAY. THE PATIENT WOULD CONTINUE TO BE MONITORED INPATIENT. IT WAS REPORTED THE HCP¿S THOUGHTS ABOUT WHAT MAY HAVE TRANSPIRED WERE THAT THE PATIENT WAS NOT PREVIOUSLY RECEIVING MEDICATION THROUGH THE CATHETER THAT WAS EXPLANTED AND/OR THERE WAS MORE MIXING OF THE PRIMING BOLUS INTO THE CSF (CEREBROSPINAL FLUID) ALTHOUGH THE PRIMING BOLUS WAS PROGRAMMED TO INFUSE OVER ONE HOUR. IT WAS FURTHER REPORTED IT WAS NOT DETERMINED WHAT CAUSED THE PATIENT¿S SYMPTOMS. NO OTHER TROUBLESHOOTING HAD BEEN DONE. NO ADDITIONAL INFORMATION WAS GATHERED IN REGARDS TO THE CAUSE OF THE OVERDOSE SYMPTOMS AND NO ADDITIONAL ACTIONS HAD BEEN TAKEN. THE PATIENT WAS REPORTEDLY CURRENTLY DOING WELL AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321682 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| R