BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED

    MDR report key: 216154 · Received March 26, 1999

    Report

    Report Number
    6000030-1999-00082
    Event Type
    Other
    Date Received
    March 26, 1999
    Date of Event
    June 1, 1998
    Report Date
    February 5, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A SYNCHROMED PUMP AND CATHETER ON 08/06/1997 FOR TREATMENT OF INTRACTABLE SPASTICITY RELATED TO CEREBRAL PALSY. THE PT DEVELOPED AN INFECTION OF SPINAL ORTHOPEDIC RODS AND THE INFECTION EXTENDED INTO THE CATHETER TRACT AND PUMP POCKET. THE PUMP AND CATHETER WERE SUBSEQUENTLY REMOVED ON 06/01/1998 AND THE PT RECOVERED WITH ANTIBIOTIC THERAPY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| O 8703W INTRASPINAL CATHETER.