BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4221615 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20873
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 13, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION DID RESOLVE AND THE PATIENT WOULD BE RE-IMPLANTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPERATIVELY THE PATIENT DEVELOPED AN INFECTION OVER THE TOP OF THE PUMP; DEVICE POCKET. THE PATIENT BUMPED INTO A DOOR KNOB AND AN UNKNOWN TYPE OF INFECTION DEVELOPED NEAR THE INCISION OF THE PUMP POCKET ALONG WITH REDNESS AND SWELLING AT THE PUMP INCISION SITE. THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT¿S LAST AND INITIAL REFILL WAS (B)(6) 2014. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS REQUIRED. INITIALLY IT WAS UNKNOWN IF CULTURES WERE TAKEN BUT LATER NOTED ONE WAS OBTAINED OF THE PUMP POCKET. THE ORGANISM WAS UNKNOWN AND INTRAVENOUS ANTIBIOTICS WERE NECESSARY. THE CAUSE OF THE ISSUES WAS REPORTED AS NOT DETERMINED BUT THE ISSUE WAS RESOLVED. A PORTION OF THE DEVICE SYSTEM, THE PUMP, WAS EXPLANTED AND DISCARDED BY THE CUSTOMER. THE PATIENT WAS TO BE RE-IMPLANTED IN THE FUTURE. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. REPORTEDLY, THIS DEVICE SYSTEM DELIVERED HYDROMORPHONE BUT WAS LATER NOTED TO HAVE DELIVERED MORPHINE. ALTHOUGH THE PATIENT¿S CURRENT OUTCOME WAS REQUESTED, THE PATIENT¿S CURRENT STATUS REMAINS UNKNOWN. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703042 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention