BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 212695 · Received February 26, 1999

    Report

    Report Number
    6000030-1999-00062
    Event Type
    Malfunction
    Date Received
    February 26, 1999
    Date of Event
    January 4, 1999
    Report Date
    January 22, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A SYNCHROMED PUMP AND CATHETER ON O7/11/1994 FOR INTRATHECAL DELIVERY OF BACLOFEN TO TREAT INTRACTABLE SPASTICITY DUE TO CEREBRAL PALSY. ON 12/11/1998 THE PT EXPERIENCED SPASMS AND JERKING. THE PT'S MOM STATED SHE DID NOT HEAR THE PUMP ALARM. THE PT PRESENTED TO HIS PHYSICIAN'S OFFICE AND PROCEEDED TO PUMP EXPLANTATION AND WAS IMPLANTED WITH ANOTHER SYNCHROMED PUMP ON 01/04/1999. ON FOLLOW UP, THE PT'S JERKING AND SPASMS HAVE RESOLVED. THE EXPLANTED PUMP HAS NOT RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization 07/11/1994, STATUS UNKNOWN.| MODEL 8703W INTRASPINAL CATHETER IMPLANTED