BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170160 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10377
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD MULTIPLE FALLS AND STRUCK THE PUMP SITE AT LEAST TWICE. THE PUMP SITE WAS REPORTEDLY OPEN AS A RESULT. THE HEALTH CARE PROVIDER (HCP) HAD CULTURED THE SITE AND IT WAS NEGATIVE. THE ENTIRE DEVICE SYSTEM WAS EXPLANTED. AT THE TIME OF EXPLANT, THE HCP RE-CULTURED THE SITE IN THE OPERATING ROOM HOWEVER THE REPORTER DID NOT HAVE THE RESULTS. THE PATIENT WAS CURRENTLY TAKING ORAL ANTIBIOTICS. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THE DEVICE WAS REMOVED DUE TO ¿INFECTION (ORGANISM)¿. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND THAT THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271142 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention