BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962236 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02663
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PARTIAL LUNG COLLAPSE SHORTLY FOLLOWING SURGERY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THE CATHETER WAS REPORTED TO HAVE BEEN AT THE HIGH THORACIC PLACEMENT, BUT IT WAS NOT THOUGHT THAT THE CATHETER LOCATION CAUSED THE ISSUED BECAUSE LUNG NERVES ASSOCIATED WITH CERVICAL NERVES. THE PATIENT EXPERIENCED SYMPTOMS ASSOCIATED WITH LUNG COLLAPSE; HOWEVER, THESE SYMPTOMS WERE NOT PROVIDED. PATIENT REQUIRED HOSPITALIZATION, MEDICAL INTERVENTION AND THE PUMP WAS REPROGRAMMED. PATIENT OUTCOME WAS UNKNOWN. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT RECOVERED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66049 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R