BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203116 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04817
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    September 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(6), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8 709SC LOT# SERIAL# (B)(6), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A MAGNETIC RESONANCE IMAGING (MRI) PERFORMED ON HER THORACIC AREA (PUMP IS LOCATED UNDER BREAST AMONG RIB AREA) TO RULE OUT A CATHETER TIP GRANULOMA. THE PATIENT EXPERIENCED SYMPTOMS OF BEING VERY DIZZY, FELT LIKE SHE WOULD PASS OUT EVERY TIME SHE LAY DOWN. IT WAS NOTED THAT A STUDY WAS DONE ON HER CAROTID ARTERY THAT WAS ¿COMPLETELY CLEAR.¿ THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL. THE PATIENT OUTCOME WAS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302222 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other