BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802395 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08779
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 11, 2014
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/DEVICE EVALUATION: ANALYSIS OF THE PUMP REVEALED ¿NO ANOMALY FOUND¿.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY. A TISSUE OCCLUSION ON THE PUMP SIDE OF THE CATHETER-PUMP INTERFACE OCCURRED. THE CATHETER WAS PATENT. THE PUMP WAS REPLACED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT NO ROTOR STUDY OR DYE STUDY WAS PERFORMED. FOLLOWING THE PUMP REPLACEMENT, THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS LATER REPORTED THAT THERE WAS TISSUE BUILD-UP IN THE PUMP PORT/CATHETER CONNECTION THAT INFILTRATED DRUG FLOW. ON (B)(6) 2014, THE PATIENT¿S FAMILY NOTICED A CHANGE/INCREASE IN THE PATIENT¿S SPASTICITY LEVELS, SO THEY SUSPECTED THAT SOMETHING WAS WRONG WITH THE DEVICE SYSTEM. WHEN THE PATIENT WAS SEEN ON (B)(6) 2014, THE PATIENT SEEMED FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS CONCERN FOR A RECENT BACLOFEN WITHDRAWAL AND ILLEGIBLE. THE PATIENT UNDERWENT IMAGING BUT THIS DID NOT DEMONSTRATE ANY DISCONTINUITY DUE TO THE BACLOFEN PUMP OR SYSTEM. HOWEVER, THERE WAS STILL CONCERN THAT THE PATIENT HAD BEEN SYMPTOMATIC AND THERE WERE NO OTHER ISSUES AFTER INTERROGATION OF THE SYSTEM. A PUMP REVISION OCCURRED EARLIER THIS YEAR AND SOME FLUID WAS NOTED AROUND THE POCKET SITE. ON EVALUATION OF THE PUMP, DEBRIS WAS NOTED AT THE PROXIMAL END OF THE CATHETER AND INSIDE OF THE PUMP AS WELL. THERE WAS CONCERN THAT THIS MIGHT HAVE BEEN WHAT WAS CAUSING SOME POSSIBLE FAILURE. OF NOTE, THERE WAS DISTAL CEREBROSPINAL FLUID (CSF) FLOW THAT WAS OCCURRING SPONTANEOUSLY COMING OUT OF THE CATHETER AND AFTER THE PUMP POCKET WAS FLUSHED. THE SURGEON AND TEAM WERE ABLE TO SEE THE FLUID COME OUT OF THE DISTAL END. THE DECISION WAS MADE, DUE TO THE AMOUNT OF DEBRIS AT THE PUMP SITE, TO IMPLANT A NEW PUMP. THE DEVICE MALFUNCTION WAS NOTED AS THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING WELL SINCE REPLACEMENT AND WAS RECEIVING EFFECTIVE THERAPY. NO ISSUES OR PERMANENT ISSUES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281447 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention