BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4222613 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20884
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER COMPLETELY BROKE, CAUSING BACLOFEN TO LEAK INTO SUBCUTANEOUS (SQ) TISSUES. X-RAYS AND A DYE STUDY HAD BEEN PERFORMED. THE PATIENT REQUIRED HOSPITALIZATION AND A CATHETER REVISION, WHICH INVOLVED THE PARTIAL EXPLANT OF THE CATHETER. THE PATIENT EXPERIENCED INCREASED SPASTICITY AT AN UNKNOWN LOCATION AS A RESULT OF THIS EVENT. THE PRODUCT ISSUE WAS RESOLVED, BUT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PUMP WAS USED TO INFUSE GABLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705547 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Hospitalization| R