BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3911236 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12478
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE CATHETER (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTED PUMP POCKET. IT WAS ALSO REPORTED THE PATIENT WAS SEEN FOR AN UNSCHEDULED OFFICE VISIT AND WAS EXAMINED ON 2014 (B)(6). EXAMINATION SHOWED ABNORMAL REDNESS, SWELLING AND DRAINAGE FROM THE INCISION SITE. IT WAS NOTED THE SEVERITY WAS MODERATE AND SYMPTOMS INCLUDED A RED INCISION SITE AND DRAINAGE FROM INCISION. A CULTURE WAS TAKEN AND SHOWED (B)(6). THE PUMP WAS EXPLANTED AND NOT REPLACED ON 2014 (B)(6) AND THE PATIENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON 2014 (B)(6). IT WAS FURTHER REPORTED THE PUMP WAS BEING USED TO DELIVER FENTANYL AND BUPIVACAINE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE PUMP, PROCEDURE, OR PROGRAMMING/REFILL. IT WAS FURTHER REPORTED ON (B)(6) 2014 THERE WAS A CONSULTATION WITH AN INFECTIOUS DISEASE SPECIALIST AND INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED. THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT RESULTED IN A MEDICAL OR SURGICAL INTERVENTION AND RESULTED IN A SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT. IT WAS NOTED THE EVENT DID NOT RESULT IN A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE AND DID NOT RESULT IN A HOSPITALIZATION. THE EVENT WAS RELATED TO THE PUMP/PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ON 2014-05-21 LABORATORY TESTING WAS ABNORMAL AND THE INCISIONAL DRAINAGE SHOWED STAPHYLOCOCCUS (STAPH) AUREUS. IT WAS ALSO REPORTED ¿SURGICAL ABANDONMENT/CAPPED¿ OCCURRED ON (B)(6) 2014. ON (B)(6) 2014 THE PUMP WAS ¿EXPLANTED/NOT REPLACED¿ AND ¿CATHETER REVISION, CONNECTED TO PUMP¿ OCCURRED. CONFLICTING PROCEDURE DATES WERE REPORTED AND IT WAS UNCLEAR WHAT REMAINED IMPLANTED IN THE PATIENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385959 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention