BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4860154 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-12004
    Event Type
    Injury
    Date Received
    June 22, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8575, LOT# N101393, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# L56457, IMPLANTED: (B)(6) 1998, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE DEVICE POCKET. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE ONSET/DIAGNOSE OF THE INFECTION WAS (B)(6) 2015. THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT EXPERIENCED SYMPTOMS OF REDNESS, SWELLING, AND PAIN. A CULTURE WAS OBTAINED AND THE ORGANISM WAS FOUND TO BE (B)(6). INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AND THE INFECTION RESOLVED. THE PATIENT EXHIBITED THE RISK FACTOR OF POST-OPERATION WOUND OR SKIN CONTAMINATION. THE PUMP WAS USED TO DELIVER GABLOFEN (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402866 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention