BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDA

    MDR report key: 5289915 · Received December 11, 2015

    Report

    Report Number
    3007566237-2015-03772
    Event Type
    Injury
    Date Received
    December 11, 2015
    Report Date
    November 16, 2015
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-40, SERIAL# (B)(4), PRODUCT TYPE: PUMP. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A REPRESENTATIVE REGARDING A PATIENT IN (B)(6) WHO WAS RECEIVING AN MORPHINE 2 MG/ML, DOSE NOT PROVIDED, VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS FAILED BACK SYNDROME (FBSS). THE MEDICAL HISTORY WAS UNKNOWN AT THE TIME OF THE REPORT. THE PATIENT'S CONCOMITANT MEDICATIONS COULD NOT BE OBTAINED. THE IMPLANT AND EXPLANT DATES OF THE CATHETER WERE NOT OBTAINABLE. IT WAS REPORTED THAT IN (B)(6) OF 2015 THE PATIENT SHOWED ABSTINENCE SYMPTOMS AND THERE WERE DIFFERENCES DURING A REFILLING SESSION, THE DIFFERENCES NOT RECORDED. FURTHER CHECKING REVEALED THAT A GRANULOMA WAS AT THE HIGH OF "BWK8". A NEW ASCEND A CATHETER WAS IMPLANTED IN (B)(6) 2015 AND CONNECTED TO THE IMPLANTED PUMP (TIP BWK 1)- "CRANIAL THE GRANULOMA". AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE LOT NUMBER OF THE CATHETER AND THE REPLACEMENT CATHETER, EVENT DATE OF THE GRANULOMA, ACTIONS PERFORMED TO DETERMINE THE GRANULOMA AND DATES INVOLVED. HOWEVER, THERE WAS REPORT THAT THERE WAS VERY "FEW" INFORMATION AVAILABLE CONCERNING THIS EVENT AND NOTHING FURTHER WAS PROVIDED. ADDITIONAL ATTEMPT WAS MADE TO VERIFY THE MORPHINE DOSE AT THE TIME OF THE EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON 2016-01-04, ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT'S DAILY DOSE OF MORPHINE WAS 2 MG/D IN COMBINATION WITH CLONIDINE (UNKNOWN DOSE).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE SPECIFIC VOLUME DISCREPANCY, DEFINITION OF BWK8, CLARIFICATION OF BWK1, CRANIAL THE GRANULOMA, CONFIRMATION OF LOCATION OF THE GRANULOMA- TIP OF THE CATHETER, THE RELATIONSHIP OF THE VOLUME DISCREPANCY AND THE GRANULOMA, THE CONCENTRATION AND DOSE OF THE CLONIDINE, AND RESOLUTION OF THE GRANULOMA. HOWEVER, THE REPRESENTATIVE HAD NO FURTHER INFORMATION ABOUT THIS CASE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818615 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8781 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention