BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 210631 · Received February 16, 1999

    Report

    Report Number
    6000030-1999-00047
    Event Type
    Malfunction
    Date Received
    February 16, 1999
    Date of Event
    December 25, 1998
    Report Date
    January 25, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER HEALTHCARE PROFESSIONAL: PT HAD A SYNCHROMED PUMP IMPLANTED ON 08/08/1996 WITH INTRATHECAL BACLOFEN THERAPY FOR RELIEF OF SPASTICITY DUE TO A SPINAL CORD INJURY AND QUADRIPLEGIA. HE WAS MAINTAINED ON A STABLE DOSE OF BACLOFEN. ON 12/25/1998 HE WAS ADMITTED TO A HOSPITAL WITH LETHARGY. THE PUMP WAS STOPPED AND BACLOFEN FROM THE PUMP COULD NOT BE ASPIRATED. THE PUMP WAS EXPLANTED 1/13/1999 AND ANOTHER SYNCHROMED PUMP WAS IMPLANTED. ON FOLLOW-UP, THE PT HAS RECOVERED FROM THE REIMPLANTATION AND IS DOING WELL WITH NO RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization IMPLANTED 08/08/1996,| MODEL 8703W INTRASPINAL CATHETER,| EXPLANTED 01/13/1999.