BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3970446 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02133
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE. NEUROSTIMULATOR PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    MCMULLIN, C. M., JADAV, A. M., HANWELL, C., BROWN, S. R. RESOURCE IMPLICATIONS OF RUNNING A SACRAL NEUROMODULATION SERVICE: A 10 YEAR EXPERIENCE. COLORECTAL DISEASE : THE OFFICIAL JOURNAL OF THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 2014. DOI: 10.1111/CODI.12686 SUMMARY: IN THIS STUDY WE REVIEWED OUR 10-YEAR EXPERIENCE OF THE MEDIUM TO LONG-TERM SUCCESS OF SACRAL NERVE STIMULATION (SNS) FOR FAECAL INCONTINENCE WITH PARTICULAR REFERENCE TO THE RESOURCE IMPLICATIONS OF RUNNING SUCH A SERVICE. ALL PERMANENT SNS IMPLANTS FOR FAECAL INCONTINENCE FROM 2001 TO 2012 WERE IDENTIFIED FROM A PROSPECTIVE DATABASE. THE PATIENTS UNDERWENT A 3 AND 6 MONTHLY FOLLOW UP WITH ANNUAL REVIEW THEREAFTER. THEY WERE DIVIDED INTO FOUR GROUPS: GROUP 1 PATIENTS OPTIMISED AFTER TWO REVIEWS, GROUP 2 PATIENTS OPTIMISED AFTER FURTHER REVIEW, GROUP 3 PATIENTS FAILED TO REACH A SATISFACTORY STATE AND GROUP 4 PATIENTS HAD A GOOD INITIAL RESULT WITH SUBSEQUENT FAILURE. EIGHTY FIVE PATIENTS UNDERWENT PERMANENT SNS WITH A MEDIAN FOLLOW UP OF 24 (3-108) MONTHS. GROUP1 INCLUDED 30 (35%) PATIENTS, GROUP 2 27 (32%) (MEDIAN ADDITIONAL VISITS 2 [2-6]), GROUP 3 18 (21%) (MEDIAN ADDITIONAL VISITS 6 [3-10]) AND GROUP 4 10 (12%) PATIENTS (MEDIAN INTERVAL TO FAILURE 54 [24-84]) MONTHS. TWENTY SEVEN % OF OUR PATIENTS HAD AN UNSATISFACTORY OUTCOME AND THE COST OF FOLLOW UP FOR THESE PATIENTS WAS £36,854 (48.7% OF THE TOTAL FOLLOW UP COSTS). THE STUDY HIGHLIGHTS THE SIGNIFICANT RESOURCE IMPLICATIONS OF RUNNING AN SNS SERVICE WITH A LARGE PROPORTION OF PATIENTS REQUIRING PROLONGED REVIEW WITH OVER A QUARTER HAVING AN UNSATISFACTORY OUTCOME AT A SUBSTANTIAL COST. REPORTED EVENTS: 1. 1 PATIENT HAD THE DEVICE REMOVED DUE TO DAMAGE AFTER A FALL. 2. 2 PATIENTS REQUIRED REPOSITIONING OF THE BATTERY AT A MEDIAN OF 18.5 MONTHS. 3. 2 PATIENTS REQUIRED A CHANGE OF THE ELECTRODE AT A MEDIAN OF 12 MONTHS. 4. 1 PATIENT HAD RE-IMPLANTATION OF A PERMANENT ELECTRODE 6 MONTHS AFTER INITIAL INSERTION DUE TO POOR SYMPTOM CONTROL DESPITE A GOOD RESPONSE DURING THE PERIPHERAL NERVE EVALUATION (PNE). 5. 5 PATIENTS HAD AN UNSATISFACTORY OUTCOME. THE REPORTER STATED THAT THE PATIENTS REQUIRED A BATTERY CHANGE AT A MEDIAN OF 72 MONTHS FROM IMPLANT WHICH RESULTED IN OPTIMIZATION. 6. 1 PATIENT HAD THE DEVICE SWITCHED OFF DUE TO DAMAGE TO THE DEVICE. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: PERIPHERAL NERVE EVALUATION LEAD MODEL 3057, PERMANENT TINED LEAD MODEL 3889 AND MODEL 3093. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447922 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention