BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1990800 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-00989
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 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
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED LACK OF THERAPEUTIC EFFECT WITH INCREASED PAIN. THE CATHETER WAS KINKED AND A VOLUME DISCREPANCY WAS NOTED; THE HCP ASPIRATED 4CC MORE THAN THE INTERROGATED RESERVOIR VOLUME THAT WAS PRESENT ON (B)(6) 2011. THE PUMP WAS REPLACED. THE PUMP WAS "FLIPPING" IN THE PUMP POCKET WHICH RESULTED IN THE PUMP HAVING TO BE RE-ANCHORED ON (B)(6) 2011. THE PT EXPERIENCED NEW SYMPTOMS OF NAUSEA SINCE THEY WERE DISCHARGED FROM THE HOSPITAL AFTER THE REPLACEMENT SURGERY. THE MEDICATIONS WERE ADJUSTED AND THE PT WAS PRESCRIBED ORAL PHENERGAN 25MG EVERY SIX HOURS AS NEEDED ON (B)(6) 2011. THE EVENT WAS REPORTED AS "ON-GOING". THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVACAINE, DILAUDID, DROPERIDOL AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention CATHETER: MODEL 8709, LOT# N246486015.| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG016859N.| CATHETER: MODEL 8709, LOT# N246486015| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG016859N| EXPLANTED: