BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3820612 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09256
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT# L44107, IMPLANTED: 1997 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THAT THE DATES WERE UNKNOWN. NORMAL LOGS, DYE STUDY, ROTOR STUDY, AND X-RAYS AS REPORTED BY MANAGING HCP..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND AN ALTERED MENTAL STATUS. THE HEALTH CARE PROVIDED STATED THE PATIENT WAS IN WITHDRAWAL. REPORTEDLY THERE WAS NO ALLEGED PRODUCT ISSUE. HOWEVER, THE PATIENT REQUIRED HOSPITALIZATION, MEDICAL INTERVENTION INCLUDING BEING PUT ON ORAL MEDICATIONS AND DEVICE REPROGRAMMING. THE PATIENT WAS SCHEDULED FOR A PUMP EXPLANT/REPLACEMENT ON (B)(6) 2014. TROUBLESHOOTING INCLUDED A DYE STUDY, A ROTOR/ROLLER STUDY, X-RAYS AND CHECKING THE LOGS. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED OR IF THE CAUSE OF THE EVENT WAS DETERMINED. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300236 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R