BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113750 · Received June 2, 2011

    Report

    Report Number
    3007566237-2011-03910
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD BEEN EXPERIENCING SYMPTOMS OF WITHDRAWAL/NAUSEA FOR (B)(6). THE PT FELT BETTER AFTER GIVING THEMSELVES A BOLUS WITH THEIR PTM (PATIENT THERAPY MANAGER). THE HCP FELT THAT THE PUMP WAS NOT WORKING. THE HCP THOUGHT THE PUMP WAS STARTING AND STOPPING. HE FELT THAT THE PT WAS GETTING DRUG FROM THE PTM BOLUSES AND THAT WAS STARTING THE PUMP AND THEN IT WAS STOPPING AFTER THAT AND THE PT WAS GOING THROUGH WITHDRAWAL. THE PUMP LOGS WERE CHECKED AND THE LOGS DID NOT SHOW MOTOR STALLS OR ERRORS. A DYE STUDY WAS SUCCESSFUL; THE CAP (CATHETER ACCESS PORT) ASPIRATED EASILY AND "MYELOGRAM WAS GOOD", SO THEY DECIDED TO REPLACE THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE (50 MG/ML) AND CLONIDINE (500 MCG/ML). THE PT WAS STILL HAVING NAUSEA AFTER THE PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R CATHETER: MODEL 8711, LOT# N080800002| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL PUMP, LOT# UNK| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PTM, LOT# UNKNOWN| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL PUMP, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PTM, LOT# UNK| CATHETER: MODEL 8711, LOT# N080800002