BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1012964 · Received March 13, 2008

    Report

    Report Number
    3004209178-2008-01226
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    October 24, 2007
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO INFECTION. THE ONSET OF THE INFECTION WAS IN 2007. THE PT EXPERIENCED REDNESS, SWELLING, PAIN AND POCKET EROSION. THE PRIMARY SOURCE OF THE INFECTION WAS THE DEVICE POCKET; OGRANISM IS UNK. THE PT DID NOT HAVE MENINGITIS. THE PT WAS TREATED WITH INTRAVENOUS AND ORAL ANTIBIOTICS AND THE DEVICE SYSTEM WAS EXPLANTED. THE INFECTION RESOLVED; THE PT DID NOT EXPERIENCE DRUG WITHDRAWAL SYMPTOMS. THE PT WAS DESCRIBED AS MALNOURISHED OR EXTREMELY THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER MODEL 8575 LOT# N076422 IMPLANTED:| IMPLANTED:| STIM ACCESSORY MODEL 8590-1 LOT# J0326417R| CATHETER MODEL CATHETER LOT# UNK IMPLANTED:| EXPLANTED: