BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3103613 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07480
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 15, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, PRODUCT TYPE CATHETER; PRODUCT ID 8709, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH. PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT DYE WAS NOT ABLE TO BE PUSHED DOWN THE CATHETER DURING DIAGNOSTICS. THE CATHETER CONNECTION TO THE PUMP WAS RESEATED AND, AT THE TIME OF THE REPORT, WAS RUNNING WITHOUT ISSUE. IT WAS BELIEVED THAT THE CAUSE WAS MISALIGNMENT OF THE CATHETER CONNECTOR WHEN THE PUMP WAS REVISED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP CONTAINED 30 ML OR MORE IN THE RESERVOIR AT REFILL, AND IT SHOULD HAVE CONTAINED ROUGHLY 3 ML. IT WAS UNKNOWN WHETHER THERE WAS A PUMP OR CATHETER FAILURE AT THE TIME OF THE REPORT. THE PATIENT'S OUTCOME WAS NOTED AS "NO HARM." THE MEDICATION USED WITHIN THE SYSTEM WAS COMPOUNDED BACLOFEN. THE PATIENT'S PHYSICIAN WAS NOTED TO HAVE CHECKED FOR CATHETER PATENCY BEFORE CONNECTING TO THE PATIENT'S NEW PUMP. IT WAS LATER REPORTED THAT THERE WAS STILL 30-37 ML IN THE PUMP AND NO MESSAGES TO INDICATE POR/MOTOR STALLS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP WAS PERFORMING CORRECTLY. THE SURGEON TEMPORARILY EXPLANTED THE DEVICE AND PROGRAMMED IT TO GIVE A BOLUS OVER SIX MINUTES, AT WHICH POINT FLUID WAS CLEARLY OBSERVED EXITING THE CATHETER PORT. THE CATHETER ALSO APPEARED TO BE PATENT, SO THE SURGEON BELIEVED THAT THE CATHETER AND PUMP WERE MIS-CONNECTED IN THE PREVIOUS PROCEDURE. IT WAS LATER REPORTED THAT THE SUSPECTED MISALIGNMENT OCCURRED WITH AN 8709 CATHETER.

    Description of Event or Problem · 1

    IT FURTHER REPORTED THAT A VOLUME DISCREPANCY WAS NOTED. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 5 MILLILITERS (ML) AND THE ACTUAL RESERVOIR VOLUME (ARV) WAS 33 ML. DIAGNOSTIC TESTING INCLUDED X-RAYS AND A DYE STUDY. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS ALSO REPORTED THAT THE PUMP HAD BEEN INVESTIGATED ¿IN THEATRE¿ PREVIOUSLY DUE TO A VOLUME DISCREPANCY BUT WHEN DISCONNECTED AND TESTED BOTH CATHETER AND PUMP WERE FUNCTIONING. SUBSEQUENTLY, THERE WAS REPORT THAT OTHER VOLUME DISCREPANCIES OCCURRED LEADING TO THE REMOVAL OF THE PUMP ON 03-19-2014. THE PATIENT HAD EXPERIENCED LESS THAN 50% THERAPY RELIEF WITH THE LOCATION NOTED AS THE DEVICE POCKET. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203299 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention