BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3443685 · Received November 1, 2013

    Report

    Report Number
    3004209178-2013-20062
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    October 12, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N152935, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. FINAL ANALYSIS OF THE CATHETER FOUND NO CORING OR TEARS IN THE CUP OF THE SUTURELESS CONNECTOR, BUT THE FLOOR OF THE SEAL APPEARED TO BE STRETCHED AND PUSHED DOWN. LEAKING WAS SEEN COMING FROM THE TOP OF THE CONNECTOR DURING PRESSURE TESTING.

    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 THERE WAS A POSSIBLE CATHETER BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTED THE CATHETER WAS KINKED AT THE ANCHOR. THE PATIENT WAS HOSPITALIZED; A REVISION WAS PERFORMED, AND THE CATHETER WAS EXPLANTED AND REPLACED. THE PUMP WAS ALSO EXPLANTED AND REPLACED AT THAT TIME AND IT WAS NOTED THERE WAS NO ALLEGED PRODUCT ISSUE AGAINST THE PUMP. THE PATIENT HAD UNDERDOSE SYMPTOMS OF RETURN OF SPASTICITY. THE LOCATION OF THE ISSUE WAS REPORTED AS THE CATHETER TRACK. THE PUMP SYSTEM WAS BEING USED TO DELIVER GABLOFEN. IT WAS FURTHER REPORTED THAT THE PHYSICIAN NOTICED A ¿LINK¿, AND THAT THE PATIENT WAS ¿OKAY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562826 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R