BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4192510 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20153
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, FLUOROSCOPY WAS PERFORMED AND SHOWED THAT THE PUMP WAS MOBILE IN THE POCKET. THE PUMP HAD BROKEN FROM THE SUTURES; HOWEVER, THE SUTURES REMAINED IN THE FASCIA. THE CATHETER HAD KINKED AT THE PUMP POCKET SITE DUE TO THE PUMP MOVING/SPINNING IN THE POCKET. ON (B)(6) 2014, A REVISION WAS PERFORMED AND THE CATHETER WAS SPLICED. THE EVENT WAS RELATED TO THE DEVICE AND WAS UNLIKELY RELATED TO THE IMPLANT PROCEDURE. THE SEVERITY WAS NOTED AS ¿MILD¿; THE EVENT OUTCOME WAS UNCLEAR AS IT WAS REPORTED THAT THE EVENT RESOLVED WITH SEQUELA AND ALSO WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER HYDROMORPHONE AND BACLOFEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672328 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention