BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2831237 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10222
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 15, 2012
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL # 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNK; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    THE PATIENT HAD THE PUMP REFILLED ON (B)(6) WITH 40 ML. THE PATIENT DID NOT REPORT ANY SYMPTOMS OF OVERDOSE IN THE REFILL CYCLE. AN UNDERDOSE WAS REPORTED. THE PATIENT HAD THE SYMPTOMS OF BACLOFEN WITHDRAWAL SUDDENLY ON (B)(6) 2012. THE PATIENT EXPERIENCED HYPERTONIA, PRURITUS AND AGITATION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM. THE PATIENT WAS GIVEN ORAL BACLOFEN. THE PUMP WAS INTERROGATED ON (B)(6) 2012. THE ACTUAL RESIDUAL VOLUME (ARV) 0ML WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV) 10.4ML. THE PROGRAMMER SAID THE PUMP HAD 10.4 ML LEFT IN THE RESERVOIR WHEN THE PUMP WAS INTERROGATED ON (B)(6) 2012 BUT THEN WHEN ASPIRATED ON (B)(6) 2012 IT WAS EMPTY. THE CATHETER ACCESS PORT WAS ASPIRATED AND EVERYTHING WAS NORMAL ON (B)(6) 2012. THE CAUSE OF THE DISCREPANCY WAS UNKNOWN. THE PATIENT WAS DOING WELL WITH A RETURN OF THERAPY. THE PUMP WAS DELIVERING LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention