BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1971573 · Received January 25, 2011

    Report

    Report Number
    3004209178-2011-00589
    Event Type
    Injury
    Date Received
    January 25, 2011
    Report Date
    January 18, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS REFILLED (B)(6) 2010, THE PTM (PERSONAL THERAPY MANAGER) DISPLAYED '8503 PHYSICIAN BOLUS IN PROGRESS' MESSAGE. ON (B)(6) 2011, IT WAS REPORTED THE PT HAD OR WOULD HAVE SURGERY TO FIX A PROBLEM WITH THE PUMP SYS. THE PT WAS NO LONGER HAVING PROBLEMS WITH THE SYS AND THE PROBLEMS WERE NOT RELATED TO THE SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N174319002| PROGRAMMER: MODEL PTM, LOT# UNK| IMPLANTED,