BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE DRUG INFUSION PUMP

    MDR report key: 12046255 · Received June 22, 2021

    Report

    Report Number
    2182207-2021-01106
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    January 11, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID NEU_UNKNOWN_CATH LOT# SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE CATHETER CITATION: ODELL DW, ALBRECHTSEN RD, SINDT JE, ET AL. THE EFFECT OF MEASURED RADIOTHERAPY DOSE ON INTRATHECAL DRUG DELIVERY SYSTEM FUNCTION. NEUROMODULATION. 2021.10.1111/NER.13372 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ODELL DW, ALBRECHTSEN RD, SINDT JE, ET AL. THE EFFECT OF MEASURED RADIOTHERAPY DOSE ON INTRATHECAL DRUG DELIVERY SYSTEM FUNCTION. NEUROMODULATION. 2021.10.1111/NER.13372 SUMMARY: OBJECTIVES: RADIATION THERAPY (RT) AND INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) ARE OFTEN USED CONCURRENTLY TO OPTIMIZE PAIN MANAGEMENT IN PATIENTS WITH CANCER. CONCERN REMAINS AMONG CLINICIANS REGARDING THE POTENTIAL FOR IDDS MALFUNCTION IN THE SETTING OF RT. HERE WE ASSESSED THE FREQUENCY OF IDDS MALFUNCTION IN A LARGE COHORT OF PATIENTS TREATED WITH RT. MATERIALS AND METHODS: CANCER PATIENTS WITH IDDS AND SUBSEQUENT RT AT OUR INSTITUTION FROM 2011 TO 2019 WERE ELIGIBLE FOR THIS STUDY. PATIENTS WERE EXCLUDED IN THE RARE EVENT THAT THEIR IDDS WAS MANAGED BY AN OUTSIDE CLINIC AND FOLLOW-UP DOCUMENTATION WAS UNAVAILABLE. EIGHTY-EIGHT PATIENTS AGED 22¿88 YEARS OLD (43% FEMALE, 57% MALE) REPRESENTING 106 SEPARATE COURSES OF RT WERE RETROSPECTIVELY IDENTIFIED. PATIENTS RECEIVED VARYING LEVELS OF RADIATION FOR TREATMENT OF CANCER AND CUMULATIVE DOSE TOTHE IDDS WAS CALCULATED. IDDS INTERROGATION WAS SUBSEQUENTLY PERFORMED BY A PAIN SPECIALIST. MALFUNCTION WAS RECORDED AS DEVIATION FROM THE EXPECTED DRUG VOLUME AND/OR DEVICE ERRORS REPORTED UPON INTERROGATION AS DEFINED BY THE MANUFACTURER. RESULTS: TOTAL MEASURED RT DOSE TO THE IDDS RANGED FROM 0 TO 18.0 GY (MEDIAN = 0.2 GY) WITH MEDIAN DOSE OF 0.04 GY/FRACTION (RANGE, 0¿3.2 GY/FRACTION). TEN PUMPS RECEIVED A TOTAL DOSE >2 GY AND THREE RECEIVED =5 GY. EIGHTY-TWO PERCENTAGE OF PATIENTS HAD FOLLOW-UP WITH A PAIN SPECIALIST FOR IDDS INTERROGATION AND ALL PATIENTS UNDERWENT FOLLOW-UP WITH A HEALTHCARE PROVIDER FOLLOWING RT. THERE WERE ZERO INCIDENCES OF IDDS MALFUNCTION RELATED TO RT. NO PATIENT HAD CLINICAL EVIDENCE OF RADIATION RELATED PUMP MALFUNCTION AT SUBSEQUENT ENCOUNTERS. CONCLUSIONS: WE FOUND NO EVIDENCE THAT RT IN PATIENTS WITH IDDS LED TO DEVICE FAILURE OR DYSFUNCTION. WHILE RADIATION ONCOLOGISTS AND PAIN SPECIALISTS SHOULD COORDINATE PATIENT CARE, IT DOES NOT APPEAR THAT RT DOSE IMPACTS THE FUNCTION OF THE IDDS TO WARRANT SIGNIFICANT CLINICAL CONCERN. REPORTED EVENT: OF THE 106 TREATMENT COURSES, WE FOUND ZERO INCIDENCES OF PUMP MALFUNCTION RELATED TO RT. A SINGLE PUMP MALFUNCTION EVENT WAS INVEST IGATED AND DETERMINED TO BE DUE TO KINKING OF THE CATHETER AND NOT RELATED TO THE RT. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938749 IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1