BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2161099 · Received June 17, 2011

    Report

    Report Number
    3004209178-2011-04582
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PUMP REPLACEMENT, THE PRIME DID NOT APPEAR ON THE SESSION REPORT. THE CAUSE COULD NOT BE IDENTIFIED. ON PUMP INTERROGATION RESERVOIR VOLUME READ 19.6ML CONFIRMING THE PROGRAMMED PRIME OF .424ML HAD BEEN DELIVERED. THE DRUGS INCLUDED FENTANYL: 1,000.0 MCG/ML, 99.9 MCG/DAY; BUPIVICAINE: 3.0 MG/ML, 0.2998 MG/DAY AND CLONIDINE: 200.0 MCG/ML, 19.98 MCG/DAY. THE PATIENT WAS REPORTED TO BE EXPERIENCING GOOD THERAPY. THE HCP PLANNED NORMAL TITRATION AT THE FOLLOW-UP VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N120146008| EXPLANTED: