BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760876 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08555
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK AROUND THE CATHETER. X-RAYS WERE TAKEN WHICH REVEALED THAT THE CATHETER WAS STILL IN THE INTRATHECAL SPACE. FLUID WAS NOTED BEHIND THE PUMP. THE X-RAY DID NOT SHOW THE PUMP CONNECTOR IN THE PICTURE; HOWEVER, WHEN THE PHYSICIAN OPENED THE PUMP POCKET, THE CONNECTOR WAS STILL INTACT AND CONNECTED TO THE PUMP. THE PHYSICIAN TOOK OFF THE CONNECTOR AND PUT IT ON AGAIN 'TO MAKE SURE'. THE PHYSICIAN PERFORMED A CATHETER ACCESS PORT (CAP) ASPIRATION TO MAKE SURE THE CATHETER WAS PATENT AND CONNECTED AND 'IT WAS'. IT WAS REPORTED THAT THERE WAS MORE THAN 50ML OF CSF THAT CAME OUT OF THE POCKET. THE PUMP POCKET WAS DRAINED. THE PHYSICIAN WAS TO DO A BLOOD PATCH ON THE DAY OF THE REPORT. PATIENT SYMPTOMS INCLUDED DRAINAGE, INCISIONAL WOUND OPENING, HEADACHE AND PAIN. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NO INJURY OR ADVERSE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT "DECIDED TO GET EXPLANTED". IT WAS UNCLEAR EXACTLY WHAT WAS EXPLANTED AND THE DATE OF EXPLANT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE DOCTOR CONVINCED THE PATIENT TO HAVE A BLOOD PATCH, AND ON (B)(6) 2012 THE PATIENT HAD WOUND EXPLORATION. THE PATIENT HAD A BLOOD PATCH ON (B)(6) 2012. THE PATIENT WAS SCHEDULED FOR ANOTHER PATCH ON (B)(6) 2012 BUT SHE CANCELLED AND HAD IT DONE THE FOLLOWING DAY. THE PATIENT DECIDED TO HAVE THE PUMP REMOVED, AND THE PUMP WAS EXPLANTED ON (B)(6) 2012. THE PUMP WAS SENT TO PATHOLOGY. ADDITIONAL INFORMATION INDICATED THAT THE WHOLE SYSTEM WAS EXPLANTED. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention