BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2884730 · Received December 26, 2012

    Report

    Report Number
    3004209178-2012-12207
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION AT THE POCKET SITE AND AN INFECTION. THE PUMP WAS REPLACED FOR END OF SERVICE IN (B)(6) 2012. IT WAS STATED THAT THE PATIENT WAS ON HIS SECOND PUMP DUE TO INFECTION. THE PATIENT DID NOT RETURN FOR FOLLOW-UP AT THAT TIME. ABOUT NINE MONTHS LATER, THE PATIENT PRESENTED WITH THE 'TOP HALF OF HIS PUMP EXPOSED IN THE ABDOMEN.' THE PUMP AND CATHETER (PUMP SEGMENT) WERE EXPLANTED AND REPLACED. THE PATIENT WAS HOSPITALIZED, BUT NO PATIENT SYMPTOMS OR INJURIES WERE RELATED TO THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS GOING HOME ON (B)(6). THE DRUG USED WITHIN THE SYSTEM WAS LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R