BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222431 · Received November 5, 2008

    Report

    Report Number
    2182207-2008-07228
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POCKET FILL HAD OCCURRED. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM FOR AN ISSUE UNRELATED TO HER PUMP. THE PATIENT WAS ADMITTED AND SEEN IN CONSULTATION BY A PAIN MANAGEMENT SPECIALIST. THE PUMP WAS INTERROGATED. THE PUMP WAS THEN REFILLED WITH CLONIDINE, DILAUDID AND BUPIVICAINE; "A PORTION OF THE REFILL VOLUME WAS FILLED IN THE PUMP POCKET. THE PATIENT EXPERIENCED NUMBNESS IN HER ABDOMEN; SHORTLY AFTER THAT, THE PATIENT "CODED" AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. A "WHEEL" WAS PALPATED OVER THE PUMP. ULTRASOUND DID NOT REVEAL ANY FLUID IN THE PUMP POCKET. THE HCP RECOMMENDED THAT THE PUMP BE ACCESSED TO CHECK VOLUMES; THEN SET THE PUMP TO MINIMUM RATE OR REFILL WITH SALINE. IT IS UNKNOWN IF THESE MEASURES WERE TAKEN. THE PATIENT WAS TREATED FOR OVERDOSE SYMPTOMS AND RECOVERED FROM THE EVENT.

    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 Hospitalization| L| R IMPLANTED:| CATHETER MODEL 8709 LOT# J12139R26| PROGRAMMER MODEL 8840 LOT# UNKNOWN| EXPLANTED: