BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1022015 · Received March 31, 2008

    Report

    Report Number
    3004209178-2008-01712
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS, SWELLING, DRAINAGE AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET; A CULTURE WAS OBTAINED AND STAPH A WAS ISOLATED. THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT WAS GIVEN INTRAVENOUS AND ORAL ANTIBIOTICS AND THE TOTAL DEVICE SYSTEM WAS EXPLANTED. THE EVENT WAS REPORTED AS "ONGOING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709SC LOT# N131377010| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8596SC LOT# N131155004| IMPLANTED:| EXPLANTED: