BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3830289 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09564
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED LATER REPORTED A PUMP MALFUNCTION. THIS REPORTED PUMP MALFUNCTION WAS LATER SPECIFIED OR UPDATED AS A PUMP RESERVOIR VOLUME DISCREPANCY. THE EXPECTED RESIDUAL VOLUME (ERV) WAS GREATER THAN ACTUAL RESIDUAL VOLUME (ARV), ERV: 17 CC AND ARV: 15 CC. THE CAUSE OF THE VOLUME DISCREPANCY WAS NOT SPECIFIED. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED PUMP REPLACEMENT ON (B)(6) 2014. THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) EXPLAINED THAT THE PUMP HAD CONSISTENT DISCREPANCIES IN VOLUME. THE HCP WAS CONTINUALLY WITHDRAWING LESS MEDICATION THEN PREDICTED RESIDUAL INDICATE. DIAGNOSTIC METHODS INCLUDED DEVICE INTERROGATION; RESULTS INCLUDED WITHDRAWING LESS MEDICATION THAN PREDICTED RESIDUALS INDICATE ON (B)(6) 2014. THE ETIOLOGY INDICATED THAT THE EVENT WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE PATIENT'S STATUS AT THE TIME OF EVENT WAS ALIVE - NO INJURY. THE PATIENT HAD NO SYMPTOMS. THE PATIENT'S OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. THE PUMP WAS USED TO INFUSE LIORESAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED. THE PATIENT WAS ASYMPTOMATIC AND DID NOT EXPERIENCE WITHDRAWAL SYMPTOMS, EVEN THOUGH 0ML WAS ASPIRATED FROM THE PUMP RESERVOIR. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 3.2ML. THIS DISCREPANCY OCCURRED AT A PUMP REFILL IN THE WEEK PRIOR TO THIS REPORT. THE PATIENT WAS SUPPOSED TO HAVE THE PUMP REFILLED IN EARLY (B)(6), BUT DID NOT GET IT REFILLED UNTIL THIS TIME. THE LOW RESERVOIR ALARM VOLUME WAS 2ML. THE FIRST VOLUME DISCREPANCY INFORMATION THAT THE REPORTER HAD WAS FROM A REFILL IN (B)(6) 2013, WHERE THE ACTUAL RESERVOIR VOLUME (ARV) WAS 5ML WAS LESS THAN EXPECTED. AT A REFILL IN (B)(6) 2013, THE ARV WAS 0.5ML LESS THAN THE ERV AND IN (B)(6) 2013, THE ARV WAS 3ML LESS THAN THE ERV. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307688 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention