BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3093883 · Received May 6, 2013

    Report

    Report Number
    3004209178-2013-07329
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 10, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 8835 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PTM WAS WORKING FINE, AND THE PATIENT SAW THEIR HCP A FEW WEEKS PRIOR TO THE REPORT AND "THEY COULD NOT GET IT TO WORK". A NEW PTM WAS USED BUT "IT WAS DOING THE EXACT SAME THING" AND "IT SAID THAT IT COULD NOT FIND THE PUMP". THE HCP NOTED THERE WAS "AN EXCLAMATION POINT AND A TRIAL IN THE UPPER LEFT, IN ADDITION TO A PTM ON ONE SIDE AND THE PUMP ON THE OTHER WITH AN X IN THE MIDDLE". NO SYMPTOMS WERE REPORTED. IT WAS LATER REPORTED THAT THE PUMP MAY BE FLIPPED, AND THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2013. IT WAS SUSPECTED THAT THE FLIPPED PUMP COULD CAUSE ISSUES WITH THE PTM NOT BEING ABLE TO LOCATE THE PUMP. THE MEDICATION USED WITHIN THE SYSTEM WAS FENTANYL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS A FLIPPED PUMP. THE HEALTHCARE PROVIDER NOTED THEY WERE UNABLE TO FILL THE PUMP. THERE WERE NO SIGNS OR SYMPTOMS FROM THE PATIENT. A PUMP REVISION WAS PERFORMED ON (B)(6) 2013. THE PATIENT¿S OUTCOME WAS NOTED AS ¿NO INJURY¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196701 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention