BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1920110 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10164
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 22, 2010
    Report Date
    July 26, 2025
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A "HARD TOUGH COURSE OF PAIN; PAIN ALL OVER". THE EVENT WAS REPORTED TO BE A SERIOUS ADVERSE EVENT AND A LIFE THREATENING SITUATION. THE PUMP WAS INTERROGATED AND THE EMPTY RESERVOIR ALARM WAS NOTED. THE PUMP WAS REFILLED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 23 HOURS OF OBSERVATION. THE PATIENT RECOVERED WITHOUT SEQUELA THE FOLLOWING DAY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    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 88 YR Male Life Threatening| H ACCESSORY: MODEL #8590-1, LOT #N104418| CATHETER: MODEL #8711, LOT #N101977020| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL #8590-1, LOT #N104418| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL #8711, LOT #N101977020