BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3972152 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02143
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID HAVE A HISTORY OF GRANULOMA FORMATION IN THE PAST WITH ANOTHER MANUFACTURER¿S CATHETERS. THIS WAS NOW THE PATIENT¿S THIRD CATHETER AND HE EXPERIENCED INCREASED SPASTICITY LOCATED ALONG THE CATHETER TRACK. THE EVENT BEING APPROXIMATELY (B)(6) 2014. A BOLUS INFUSION OF BACLOFEN VIA THE SYNCHROMED II PUMP ACHIEVED NO CHANGE IN SYMPTOMS/TONE. A BOLUS DIRECT INTRA-SPINAL INJECTION ALLEVIATED THE INCREASED TONE. THE CONSULTANT INDICATED IT WAS "NOT WORTH ATTEMPTING" TO ASPIRATE VIA CATHETER ACCESS PORT AND WAS NOT RESPONSIBLE FOR THE PREVIOUS REFILL PROCEDURE SO THE RESIDUAL VOLUME OF DRUG WAS NOT CHECKED NOR A DYE STUDY PERFORMED. THE ISSUE WAS REPORTED AS A CATHETER ISSUE WITH INFLAMMATORY MASS/GRANULOMA AND OCCLUSION AT THE CATHETER TIP. AT THIS TIME, THE ISSUE RESOLUTION AS WELL AS IF THE CAUSE OF THE ISSUE WAS DETERMINED WAS REPORTED AS ¿UNKNOWN-N/A." THE PLAN WAS TO REFER THE PATIENT FOR A CATHETER EXPLANT AND REPLACEMENT. THE DATE OF PLANNED EXPLANT WAS REPORTED AS (B)(6)2014. AT THE TIME OF THE EVENT, THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED COMPOUNDED BACLOFEN. FURTHER, REPORTEDLY THIS WAS A CATHETER THAT WAS NOT IN THE FIELD ACTION. ADDITIONAL INFORMATION NOTED THAT THE PATIENT¿S CATHETER WILL BE CHANGED AT THE END OF (B)(6) AS THE NEUROSURGEON WAS ON HOLIDAY CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448234 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R