BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4111160 · Received September 23, 2014

    Report

    Report Number
    3007566237-2014-02670
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS (DYSTONIA, SPASTICITY, AND LESS THAN 50% THERAPY RELIEF) FOLLOWING A RECENT PUMP EXPLANT AND REVISION OF THE PROXIMAL SECTION OF A CATHETER (SEE MANUFACTURE REPORT # 3007566237-2014-02669). DIAGNOSTIC TESTING INCLUDED X-RAYS IN WHICH IT WAS NOTED THAT THE DISTAL SEGMENT OF THE CATHETER HAD MIGRATED. THE PATIENT WAS TO UNDERGO ANOTHER REVISION TO ADDRESS THIS. IT WAS UNKNOWN IF DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, THE CAUSE OF THE ISSUE OR IF IT WAS RESOLVED. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO VERIFY THE RESOLUTION, SYMPTOMS, OUTCOME AND DRUG DELIVERED. IT WAS FURTHER REPORTED THAT THE REVISION OCCURRED TO REPLACE THE DISTAL SEGMENT. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. NO PRODUCTS WILL BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS FURTHER PROVIDED THAT SERIAL NUMBER OF THE CATHETER WAS NOT AVAILABLE. THE EXPLANTED PRODUCT WAS DISCARDED FROM THE DISTAL REVISION AND WILL NOT BE RETURNED. THE EXPLANT DATE WAS NOTED TO BE APPROXIMATE. THERE WERE NO CHANGES IN THE DRUG DELIVERED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592653 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention