BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2963798 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02705
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 17, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J11296R60, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(4) 2010, PRODUCT TYPE: ACCESSORY. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND RESIDUE AND CORROSION THROUGHOUT THE GEAR-TRAIN. SIGNIFICANT RESIDUE WAS FOUND ON THE UPPER SHAFT OF GEAR 2. ALSO, SOME RESIDUE WAS FOUND ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTS INTO THE TOP BRIDGE ASSEMBLY. FINAL ANALYSIS OF THE CATHETER FOUND INDENTATION CUTS OR TEARS SEEN IN THE SEALING SURFACE OF THE SC CUP CONNECTOR. DURING PRESSURE TESTING, A LEAK WAS SEEN FROM THE SC CONNECTOR. IT WAS ALSO NOTED THAT THERE WAS A WELL-DEFINED INDENT IN THE CUP OF THE SC CONNECTOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS "DOING WELL" SINCE THE PUMP HAD BEEN REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR INTRACTABLE NAUSEA AND VOMITING. THE PUMP STATUS LOOKED OKAY WHEN CHECKED AND THE PATIENT WAS DISCHARGED. IT WAS NOTED THAT THE PUMP LOGS HAD NOT BEEN CHECKED AT THAT TIME. THE PATIENT CAME BACK TO THE HOSPITAL FOUR DAYS LATER WITH INTRACTABLE NAUSEA, VOMITING, AND A FEVER. AT THAT TIME THE LOGS WERE CHECKED AND MULTIPLE MOTOR STALLS AND RECOVERIES WERE SEEN STARTING FROM (B)(6), THOUGH NO ALARM HAD BEEN HEARD. AT THAT TIME, THE PATIENT WAS ALSO HAVING INCREASED PAIN, BUT IT WAS BEING MANAGED WITH ORAL AND INTRAVENOUS MEDICATIONS. ADDITIONALLY, IT WAS STATED THAT THE PATIENT HAD AN MRI THE DAY PRIOR TO REPORT, BUT THERE WERE NO KNOWN MAGNETIC OR ELECTROMAGNETIC INFERENCE PRIOR TO THAT. SIX DAYS LATER, IT WAS REPORTED THAT THE PUMP HAD BEEN REPLACED. ONE WEEK AFTER THAT, IT WAS REPORTED THAT WHILE THE PUMP WAS "NON-FUNCTIONAL", THE PATIENT'S SYMPTOMS WERE BEING MANAGED WITH DURAGE SIC PATCHES, CONTROLLED "RELEASE MORPHINE SULFATE, AND INTRAVENOUS DILAUDID. IT WAS ALSO REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. THE DRUG USED IS THIS SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68873 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R