BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2031515 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02118
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND CATHETER WERE 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.

    Description of Event or Problem · 1

    THE PT HAD A HEADACHE FOR 6 MONTHS. A CEREBROSPINAL FLUID LEAD WAS SUSPECTED. THE PUMP WAS REPLACED (B)(6) 2010. THE CATHETER WAS REVISED (B)(6) 2011. ON (B)(6) 2011, BOTH THE PUMP AND CATHETER WERE REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED:| CATHETER: MODEL 8703, LOT# L58814W| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NGH034685R| IMPLANTABLE INFUSION PUMP: MODEL 8627L18,| IMPLANTED:| CATHETER: MODEL 8575, LOT# N213330| IMPLANTED: