BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3073310 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06780
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 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
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. THE CATHETER WAS INCOMPLETE; RETURNED IN SEGMENTS. ANALYSIS OF CATHETER MODEL 8596 REVEALED NO SIGNIFICANT ANOMALY FOUND. ANALYSIS OF CATHETER MODEL 8709 REVEALED THE CATHETER BODY WAS BROKEN. DURING PRESSURE TESTING A LEAK WAS NOTED 7.1 CM FROM THE PROXIMAL END OF SEGMENT 2. A HOLE WAS DISCOVERED WHERE THE LEAK WAS SEEN. AND ALSO AN ABRASION AND DEFORMED SHAPE WAS ON THE CATHETER BODY AT THE SAME LOCATION. THE AREA OF THE HOLE LOOKS SOMEWHAT JAGGED INDICATING IT IS MORE OF A RESULT OF A BREAK. THE BREAK WENT THROUGH ONE END OF THE LUMEN. VERY CLOSE TO WHERE THE ANCHOR IS ATTACHED. THE CATHETER MAY HAVE BEEN COMPRESSED IN THIS AREA.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS OF INCREASED TONE AND SPASTICITY. AN X-RAY WAS PERFORMED ON (B)(6) 2013 AND WAS NORMAL. A DYE STUDY SHOWED EXTRAVASATION OF DYE AT THE 3RD TO 4TH LUMBAR SPINAL SITE WHERE THE CONNECTOR PIN WAS LOCATED. A CATHETER BREAK AT THE CONNECTOR PIN WAS REPORTED. A REVISION WAS PERFORMED AND BOTH EXISTING 8709 AND 8596 CATHETERS WERE REPLACED. THE PUMP WAS ALSO REPLACED FOR NEARING END OF LIFE (EOL). AFTER REPLACEMENT OF THE CATHETER THE INFUSION RATE WAS DECREASED BY 10 % TO 758.7 MCG/DAY. THE PATIENT WAS ADMITTED FOR A 23 HOUR STAY TO OBSERVE FOR SIGNS/SYMPTOMS OF INTRATHECAL BACLOFEN (ITB) OVERDOSE/WITHDRAWAL. THE PATIENT STATUS WAS REPORTED AS 'ALIVE - NO INJURY/NO ADVERSE EVENT.' THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174603 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R