BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3022885 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04285
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 2, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8578 LOT# N143154, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO SEPARATE INCIDENTS OF WHAT APPEARED TO BE OVERDOSE SYMPTOMS, INCLUDING RESPIRATORY DEPRESSION AND A COMA. THE FIRST EVENT OCCURRED ON THE PRIOR WEDNESDAY AND THE SECOND OCCURRING ON THE FOLLOWING FRIDAY EVENING. EACH TIME, THE PATIENT WOULD BECOME COMATOSE FOR ABOUT FOUR HOURS BEFORE RECOVERING. IT WAS NOTED THAT THE PATIENT IS TYPICALLY HYPOTONIC DUE TO THE INTRATHECAL BACLOFEN. ADDITIONALLY, IT WAS STATED THAT A "LITTLE KINK" HAD BEEN PREVIOUSLY DETECTED IN THE CATHETER. NO ALARMS HAD BEEN HEARD AND THE REPORTER STATED THAT THE PATIENT WOULD CONTINUE TO BE EVALUATED TO TRY TO DETERMINE THE CAUSE OF THE MEDICAL ISSUES. IT WAS NOTED THAT THEY WERE NOT CERTAIN THAT THERE WAS A DIRECT CORRELATION TO THE PUMP. THE DRUG USED IN THIS SYSTEM WAS BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS HAD NOTHING TO DO WITH THE DEVICE AND THERE HAD BEEN NO OVERDOSE. THE REPORTER HAD NO FURTHER INFORMATION AND DID NOT STATE THE CAUSE OF THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125527 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R