BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2250688 · Received September 13, 2011

    Report

    Report Number
    3004209178-2011-07812
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 3, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS INITIALLY REPORTED: ACTUAL RESIDUAL VOLUME GREATER THAN THE EXPECTED RESIDUAL VOLUME. ARV: APPROX. 20 ML, ERV: APPROX. 3ML. THIS WAS THE FIRST REFILL FOLLOWING IMPLANT. PT EXPERIENCED FLU-LIKE SYMPTOMS FOLLOWING THE PUMP REPLACED AND THE PT WAS READMITTED TO THE HOSPITAL. PER REPORTER PT'S PAIN HAD ACTUALLY IMPROVED OVER (B)(6). A DYE AND ROTOR STUDY WERE PLANNED. DRUG INFUSED WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization IMPLANTABLE INFUSION PUMP: MODEL 863720,| LOT# NGP010325N| PROGRAMMER: MODEL 8835, LOT# NPG014226N| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12353R08| EXPLANTED: