BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2970426 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02920
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 25, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING. A MOTOR STALL RECOVERY WAS NOTED IN THE LOGS. DURING DESTRUCTIVE TESTING, NOTHING SIGNIFICANT WAS FOUND THAT MIGHT HAVE CAUSED THE STALL. IT WAS NOTED THAT MANY FACTORS MAY CAUSE SYNCHROMED II TO STALL, INCLUDING EMI AND MAGNETS. ANALYSIS OF THE CATHETER REVEALED A USER RELATED HOLE IN THE CATHETER BODY. A LEAK WAS OBSERVED IN THE PROXIMAL PORTION OF SEGMENT 2 BETWEEN THE 71 AND 72 CM MARK. A HOLE WAS OBSERVED ON ONE SIDE OF THE CATHETER AND ANOTHER HOLE WAS OBSERVED ON THE OTHER SIDE IN THE SAME GENERAL AREA. THESE OBSERVATIONS INDICATED A POSSIBLE NEEDLE STICK AS THE CAUSE OF THE HOLES. ADDITIONALLY, INDENTATION CUTS OR TEARS WERE OBSERVED IN THE SEALING SURFACE OF THE SC CUP CONNECTOR OF SEGMENT 1. NO LEAK WAS SEEN DURING PRESSURE TESTING OF SEGMENT 1.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS EXPLANTED DUE TO 'PUMP FAILURE.' THE CAUSE OF THE EVENT WAS NOTED AS 'UNKNOWN.' A SIDE PORT ASPIRATION WAS ATTEMPTED IN (B)(6) 2012 BUT WAS UNSUCCESSFUL. AN X-RAY REVEALED 'NO OBVIOUS PROBLEM.' A NORMAL INDIUM STUDY WAS PERFORMED IN (B)(6) 2012. MULTIPLE DOSE ADJUSTMENTS WERE MADE WITH NO CHANGES IN CLINICAL SYMPTOMS. THE PATIENT'S PUMP AND CATHETER WERE EXPLANTED IN (B)(6) 2013. THE PATIENT WAS NOTED TO HAVE EXPERIENCED SPASMS, INCREASED TONE, DIAPHORESIS, AND IRRITABILITY. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT'S OUTCOME WAS REPORTED TO BE 'NO INJURY.' THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74447 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention