BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3013236 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03981
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4) IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS POSSIBLY HAVING WITHDRAWAL SYMPTOMS. THE PATIENT'S NEXT REFILL WAS DUE IN (B)(6) 2013. ADDITIONAL INFORMATION WAS PROVIDED THAT AN X-RAY WAS PERFORMED ON (B)(6) 2013 WHICH FOUND THE PROXIMAL CATHETER SEGMENT HAD MIGRATED INTO THE PATIENT'S PERITONEAL SPACE, AND WAS COILED. THE PATIENT HAD INCREASED SPASMS, INCREASED CPK, AND INCREASED IRRITABILITY. A SURGICAL INTERVENTION OF THE CATHETER WAS PERFORMED. THE PATIENT WAS HOSPITALIZED AND RECOVERED WITHOUT SEQUELAE. THE PUMP WAS BEING USED TO DELIVER LIORESAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS LAST REFILLED ON (B)(6) 2013. THE PUMP WAS FILLED WITH GABLOFEN. IT WAS REPORTED WHEN THE CATHETER WAS REVISED IT WAS PLACED AT THE CERVICAL SPINE AND NOT THE THORACIC LEVEL AND THE PATIENT'S TRIP TO THE EMERGENCY ROOM WAS ATTRIBUTED TO THIS. THE PATIENT WENT INTO SURGERY AGAIN ON (B)(6) 2013 TO PLACE THE CATHETER THORACICALLY. THE PROBLEMS RESOLVED AND THE PATIENT HAD NO FURTHER ISSUES. IT WAS DECIDED TO DISCONTINUE THE PATIENT'S CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115466 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Hospitalization| R