BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED

    MDR report key: 312284 · Received January 10, 2001

    Report

    Report Number
    6000030-2000-00371
    Event Type
    Other
    Date Received
    January 10, 2001
    Date of Event
    April 21, 2000
    Report Date
    September 29, 2000
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A SYNCHROMED PUMP IMPLANTED ON 06/1997. PT HAD SYMPTOMS OF REDNESS, FEVER, SWELLING AND DRAINAGE. THE PRIMARY LOCATION OF INFECTION WAS THE DEVICE POCKET WHERE A CULTURE WAS TAKEN. THE TYPES OF ORGANISM CULTURED WERE CHRYEOMONAS LU TEDA, DIPHTEROID BACILLI, STREPTOCOCCUS AGALACTIAE. THE DATE THE CULTURE WAS TAKEN IS UNKNOWN. THE PT HAD THE DEVICE EXPLANTED ON 5/2000 AND WAS GIVEN IV AND ORAL ANTIBIOTICS. THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133 SYNCHROMED IMPLANTABLE INFUSION PUMP LKK MEDTRONIC INC. 861718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O TO UNK.| 8703W INDURA INTRASPINAL CATHETER IMPLANTED 1997