BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1061422 · Received June 17, 2008

    Report

    Report Number
    3004209178-2008-03288
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 19, 2008
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. CATHETER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE PUMP WAS NOT WORKING. DURING SURGERY, THE CATHETER WAS FOUND TO HAVE MULTIPLE TWISTS AND KINKS; THE PUMP HAD FLIPPED MANY TIMES. BOTH THE PUMP AND CATHETER WERE REPLACED AS THE HCP WANTED A 20CC PUMP. NO PATIENT SYMPTOMS WERE REPORTED; THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER MORPHINE, BUPIVACAINE, FENTANYL, AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT# J11753R03| PROGRAMMER MODEL 8840 LOT# UNKNOWN