BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2941818 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01256
    Event Type
    Injury
    Date Received
    February 4, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE CATHETER REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THIS PATIENT WAS REPORTED TO BE MALNOURISHED OR EXTREMELY THIN PRIOR TO THIS DEVICE SYSTEM BEING IMPLANTED. EXCORIATED SKIN OVER THE PUMP SITE RESULTED IN EXPOSED HARDWARE. THE PATIENT WAS ADMINISTERED PERIOPERATIVE AND INTRAVENOUS ANTIBIOTICS FOR THE PRESUMED INFECTION. THE CULTURES WERE NEGATIVE AND NO INFECTION WAS CONFIRMED. THE PATIENT OUTCOME WAS REPORTED THAT THE INFECTION RESOLVED. THIS SYSTEM WAS ALSO REPORTED TO HAVE DELIVERED GABLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WOUND DEHISCENCE AND A POSSIBLE INFECTION OCCURRED. THE PUMP AND CATHETER WERE EXPLANTED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45938 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention