BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093633 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03483
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A CHANGE IN THERAPEUTIC EFFECT. THE PT HAD THEIR PUMP SET TO THE LOWEST POSSIBLE SETTING AT THE DIRECTIVE OF THE PT'S DOCTOR ON (B)(6) 2011. THE PT HAD SURGERY FOR BOWEL BLOCKAGE. FOLLOWING SURGERY, THE PT HAD DRUG INTERACTION BETWEEN THE INTRATHECAL MEDICATION IN HER DEVICE AND INJECTIONS OF MORPHINE AND DILAUDID. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 60 YR Required Intervention CATHETER: MODEL 8709SC, LOT # N156295007| IMPLANTED:| EXPLANTED: