BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122781 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07997
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    August 27, 2012
    Report Date
    April 22, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED A BACLOFEN OVERDOSE. THE PATIENT WAS VERY VIOLENT, PARANOID, AND ¿FELL ABUSIVE¿ FOR FOUR DAYS FOLLOWING A PUMP AND CATHETER REPLACEMENT (SEE MANUFACTURER REPORT #3007566237-2012-00931.) THE PATIENT DID NOT REMEMBER ANY OF THAT TIMEFRAME WHILE IN THE HOSPITAL BUT HE WAS TOLD THIS BY HIS FAMILY. THE PATIENT¿S ¿DOSAGE WAS CUT BACK TO HALF OF THE PROGRAMMED RATE.¿ HE HAD SINCE HAD A REFILL AND ¿EVERYTHING WAS FINE.¿ HOWEVER, THE PATIENT REPORTED ¿GETTING MORE CRAMPY¿ AND ISSUES WITH SPASTICITY ESPECIALLY IN THE COLD. HE WAS CONCERNED WITH THE TITRATION OF MEDICINE IF THIS COULD LEAD AGAIN TO AN OVERDOSE. HE WAS TO SEE HIS PHYSICIAN ON (B)(6) 2013 FOR A REFILL AND TO ADDRESS HIS CURRENT SYMPTOMS. THIS DEVICE SYSTEM DELIVERED BACLOFEN. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A RESULT OF THE DISLODGEMENT OF THE PATIENT¿S DISTAL CATHETER. THE PATIENT HAD EXPERIENCED HALLUCINATIONS AND MENTAL STATUS CHANGES. THE PATIENT REQUIRED HOSPITALIZATION, THE CATHETER WAS REVISED AND HIS SYMPTOMS RESOLVED OVER APPROXIMATELY FOUR DAYS. THE PATIENT HAS SINCE BEEN REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS CONFIRMED TO HAVE DELIVERED COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224939 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R