BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4791759 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-09589
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). THE ARV WAS 10.6ML (ALSO MENTIONED AS 11ML) AND THE ERV 3.6ML (ALSO MENTIONED AS 3.5ML). THE PATIENT EXPERIENCED ¿MAYBE A LITTLE¿ WITHDRAWAL SYMPTOMS AND INCREASED PAIN. THE REPORTER DENIED ANY PUMP ALARMS. THE CAUSE OF THE VOLUME DISCREPANCY WAS UNKNOWN. THE HEALTHCARE PROVIDER (HCP) WAS GOING TO CHECK THE RESIDUAL VOLUME HALFWAY THROUGH A CYCLE AND RECORD THE VOLUME. THE APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT WAS ALSO TAKING FENTANYL AND PERCOCET AT THE TIME OF THE EVENT. THE PATIENT WAS GIVEN MEDICATION TO COVER PAIN/BREAK THROUGH PAIN. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336107 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR