BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2891575 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12405
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8 709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A HEADACHE. IT WAS DETERMINED VIA SURGERY THAT THE PATIENT HAD A SPINAL FLUID LEAK AT THE OLD CATHETER ENTRY SITE. THE CATHETER WAS "OK"; HOWEVER, THE PHYSICIAN WANTED TO REPLACE THE PART OF THE CATHETER THAT WAS OUTSIDE THE SPINE "JUST IN CASE". THE CATHETER WAS REVISED IN EARLY DECEMBER. THE PATIENT STATUS AT THE TIME OF THE EVENT WAS REPORTED AS "NO INJURY". THE DEVICE SYSTEM WAS DELIVERING DILAUDID. IN (B)(6), IT WAS REPORTED THAT AN MRI OF THE LUMBAR SPINE WAS SCHEDULED DUE TO FLUID COLLECTION SEEN ON CT SCAN. IT WAS NOTED THAT IT WAS UNRELATED TO THE PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention