BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1052576 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02726
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 18, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FOLLOWING A PUMP REPLACEMENT, THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND EXPERIENCED A RETURN OF SYMPTOMS. IT WAS REPORTED THAT THE CATHETER WAS KINKED IN TWO PLACES AT THE PUMP REPLACEMENT SURGERY; THE CATHETER WAS NOT REPLACED AT THAT TIME. IN 2008, THE PATIENT NOTED A RETURN OF SPASTICITY. TWO DAYS LATER, THE PATIENT WAS SEEN BY HER HCP WITH INCREASED SPASTICITY, SWEATING, AND PRURITUS. THE HCP FELT THE PATIENT WAS GOING THROUGH WITHDRAWAL AND WAS IN THE PROCESS OF SCHEDULING SURGERY WITHIN 24-48 HOURS. THE PATIENT WAS GIVEN UNSPECIFIED MUSCLE RELAXANTS AND VALIUM; THE PATIENT HAS A SEVERE REACTION TO ORAL BACLOFEN, SO IT WAS NOT SUPPLIED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8703W L48425

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention LOT# NGV414082H| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863740