BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2971341 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02927
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 11, 2012
    Report Date
    September 2, 2016
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, A CEREBROSPINAL (CSF) FLUID LEAK AND A HOLE IN THE CATHETER OCCURRED. THE DIAGNOSTIC METHODS CONSISTED OF EXAMINATION/PALPITATION, WHICH REVEALED DRAINING FROM THE INCISION SITE IN THE LOWER LUMBAR AREA, ON (B)(6) 2012 AND (B)(6) 2013. IT WAS NOTED, THE ETIOLOGY TO THIS EVENT WAS THE LUMBAR PORTION OF THE CATHETER. SURGICAL REVISION OCCURRED; THE CATHETER WAS SPLICED ON (B)(6) 2012 AND (B)(6) 2013. EXAMINATION/PALPITATION ON (B)(6) 2013 RESULTED IN FINDINGS OF NO DRAINAGE. THE PATIENT RECOVERED WITHOUT SEQUELAE AS OF (B)(6) 2013. THE DEVICE SYSTEM WAS USED TO ADMINISTER MORPHINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CLINICAL SITE INDICATED A BLOOD PATCH WAS ALSO PERFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77087 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention