BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2891799 · Received December 31, 2012

    Report

    Report Number
    3007566237-2012-03153
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    November 29, 2012
    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

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN HAD TRIED TO ASPIRATE FROM THE CATHETER ACCESS PORT, BUT HE WAS UNSUCCESSFUL. AN X-RAY SHOWED THAT THE PIN CONNECTOR MAY HAVE BEEN ON THE PERIPHERY OF THE PUMP. IT WAS ALSO STATED THAT THE "COUNT WAS CORRECT" DURING SURGERY. THE EVENT TOOK PLACE ON THE PUMP DEVICE BEING UPDATED TO THIS REPORT, WHICH IS DIFFERENT THAN THE DEVICE PREVIOUSLY REPORTED. PLEASE NOTE THAT THE PUMP MANUFACTURING INFORMATION HAS ALSO CHANGED DUE TO THE CHANGE IN DEVICE FOR THE EVENT. CONCOMITANT PRODUCTS HAVE ALSO BEEN ADDED/UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP AND CATHETER WERE REPLACED. AFTER THE REPLACEMENT SURGERY, THE PATIENT BECAME LETHARGIC, DROWSY, AND SEDATED, AND "THEY THOUGHT HE WAS HAVING AN OVERDOSE." THE PATIENT'S PHYSICIAN WANTED TO LOWER THE PATIENT'S DOSAGE. THE OLD MEDICATION USED WITHIN THE REPLACED SYSTEM WAS 2000 MCG/ML GABLOFEN. THE NEW MEDICATION USED WITHIN THE SYSTEM WAS 500 MCG/ML BACLOFEN (UNKNOWN). THE PATIENT WAS REPORTED TO BE "DOING FINE." NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Other