BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3840554 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09880
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE CATHETER, SERIAL NUMBER (B)(4), FOUND NO SIGNIFICANT ANOMALY; THE CATHETER WAS INCOMPLETE/RETURNED IN SEGMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER REVISION WAS PERFORMED ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING GOOD EFFICACY FROM THEIR PUMP. IT WAS REPORTED THAT THE CATHETER APPEARED TO BE CLOGGED, BUT WITH SCAR TISSUE, NOT GRANULOMA OR CRYSTALLIZATION. IT WAS NOTED THAT THE PATIENT¿S PUMP WAS USED TO INFUSE MORPHINE AND BUPIVACAINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN INCREASE IN PAIN BACK TO BASELINE. IT WAS NOTED THAT THERE WAS A DOSE ADJUSTMENT, BOLUSES, AND A DYE STUDY. IT WAS REPORTED THAT THERE WAS "NEGATIVE CSF ASPIRATION" AND NO RESPONSE TO DOSE CHANGE ¿¿¿. SURGERY WAS PERFORMED TO REPLACE CATHETER, WHICH IS NOW WORKING WELL. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS REPORTED THAT THE CATHETER REQUIRED REPLACEMENT DUE TO DISLODGMENT OR KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318842 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention