BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2140964 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04634
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 26, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CATHETER WAS DISRUPTED DURING A PREVIOUS SPINE SURGERY. THE CATHETER WAS DISLODGED FROM THE SPINAL SPACE. THE PT EXPERIENCED WITHDRAWAL. ON (B)(6) 2011, THE PUMP WAS ALARMING. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING; ALARM DUE TO ZERO ML RESERVOIR VOLUME REACHED. THE PUMP WAS REFILLED AND THE CATHETER WAS REPLACED. THE PT'S OUTCOME WAS REPORTED AS "SERIOUS-INJURY/ILLNESS-RECOVERED WITHOUT SEQUELAE". THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE (5 MG/ML, 0.8 MG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R EXPLANTED:| CATHETER: MODEL 8709, LOT # N100897030| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT # N257276009| IMPLANTED: