BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2931467 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01041
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER NOTED THE COMPLETE CATHETER WAS RECEIVED BUT WAS IN SEGMENTS. THE MOST DISTAL SEGMENT CONSISTED OF THE DISPENSING HOLES AND THE ATTACHED ANCHOR WHICH CONFIRMED THAT THE ORIGINAL ALLEGATION WAS INCORRECT. TWO OF THE RETURNED SEGMENTS HAD WHAT APPEARED TO BE ELECTROCAUTERY DAMAGE TO THEIR SURFACES, INDICATING THIS OCCURRED DURING THE EXPLANT PROCEDURE. MISCELLANEOUS ACCEPTABLE TESTING WAS PERFORMED AND NO SIGNIFICANT ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED:2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. IT WAS INITIALLY REPORTED THAT THERE WAS A CATHETER BREAK AT THE DISTAL SEGMENT AND IT WAS ORIGINALLY THOUGHT BY THE HEALTHCARE PROVIDER (HCP) THAT A PORTION OF THE CATHETER HAD SHEARED OFF AND WAS IN THE INTRATHECAL SPACE. IT WAS LATER REPORTED THAT THE CATHETER HAD BEEN REPLACED ON (B)(6) 2012 AND THE CATHETER WAS NOT SHEARED OFF AS INTERPRETED FROM THE EARLIER X-RAY IMAGING. THERE WERE NO PATIENT SYMPTOMS REPORTED WITH THE EVENT. THE MEDICATION BEING DELIVERED WAS LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER WAS NOT YET AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37706 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention