BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2990519 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03356
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 6, 2013
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED AN ANOMALY OF GEAR TRAIN CORROSION AND /OR LUBRICATION WEAR RELATED TO MOTOR STALL. IT WAS REPORTED THAT THE MOTOR STALL WAS DUE TO SHAFT BEARING. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP WAS NOT COMPLETED AS OF THE TIME OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER ANALYSIS IS COMPLETE

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# L64339, IMPLANTED: 1999 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL RECEIVED INFORMATION REPORTED THAT THE PATIENT WAS ¿STILL FIGHTING WITHDRAWALS.¿ IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND PAIN. IT WAS LATER REPORTED THAT IN (B)(6), THE PATIENT WAS RECEIVING 17.75MG/DAY OF DILAUDID AND WAS RESTARTED AT 0.2MG/DAY BECAUSE SHE WENT WITHOUT MEDICINE FOR A PERIOD OF TIME. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECEIVING 1.5MG/DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT WHEN THE PATIENT WAS EXPERIENCING THE SEVERE WITHDRAWALS SHE HAD GONE TO THE ER (EMERGENCY ROOM) BECAUSE SHE THOUGHT SHE HAD THE FLU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL OCCURRED ON (B)(6) 2013 AND A TUBE SET MESSAGE OCCURRED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT HAD NOT HEARD ANY ALARMS. THE PATIENT WAS NOTED TO HAVE FELT "REALLY ROTTEN" OVER THE PREVIOUS TEN DAYS, AND WAS REPORTED TO BE HAVING WITHDRAWAL SYMPTOMS. THE PATIENT WAS SCHEDULED TO SEE A NEUROSURGEON ON (B)(6) 2013. ABOUT TWO WEEKS LATER, THE PATIENT STATED THAT, AFTER HER PUMP HAD "STOPPED WORKING," SHE EXPERIENCED SEVERE WITHDRAWALS, SEVERE DEHYDRATION, SEVERE DIARRHEA, A FEVER, ANXIETY, "THE SHAKES"; SHE FELT WEAK AND LETHARGIC; HER BLOOD PRESSURE HAD BEEN HIGH, AND HER BODY HAD BEEN UNDER TREMENDOUS STRESS. THE PATIENT WAS SCHEDULED TO HAVE HER PUMP REPLACED THE FOLLOWING DAY. ABOUT ONE WEEK LATER, THE PATIENT EXPRESSED CONCERN WITH HER NEW PUMP'S DOSAGE, WHICH WAS SET TO DELIVER 0.5 MG/DAY AND WAS DECREASED FROM HER OLD PUMP'S DOSAGE OF 17.75 MG/DAY. THE PATIENT STATED THAT "SHE COULD GO INTO CARDIAC ARREST OR STOP BREATHING BECAUSE, HER BODY HAD BEEN WITHOUT THE MEDICATION FOR SO LONG". THE PATIENT'S OUTCOME WAS NOT KNOWN AS OF THE DATE OF THIS REPORT. THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. COMPANY REPRESENTATIVE REPORTED THE PUMP WAS RETURNED FOR ANALYSIS OF MOTOR STALL. COMPANY RE PRESENTATIVE INDICATED PATIENT'S SPOUSE REPORTED PATIENT WAS DOING WELL. PATIENT SPOUSE INQUIRED ABOUT THE RESULTS OF THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93809 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention