BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2690897 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06765
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Report Date
    July 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N242817, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL AND WAS ADMITTED TO THE EMERGENCY ROOM (ER). IT WAS NOTED THAT A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND INDICATED A POSSIBLE KINK OR FRACTURE IN THE CATHETER. A DYE STUDY WAS PERFORMED ON (B)(4) 2012 AND WAS NEGATIVE, SO THE PATIENT WOULD SEE A SURGEON. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THE DRUG DELIVERED VIA PUMP WAS FENTANYL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1