BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2895496 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00029
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    HILMY, M., TATAROV, O., MCQUEEN, L., SMALL. D., GRANITSIOTIS, P., CONN, I. G. SACRAL NERVE STIMULATION FOR URINARY DYSFUNCTION: THE FIRST YEAR OF THE SCOTTISH NATIONAL SERVICE. SCOTTISH MEDICAL JOURNAL. 2012;57(4):200-203. DOI: 10.1258/SMJ.2012.012117. SUMMARY: SACRAL NERVE STIMULATION (SNS) HAS BECOME AN ESTABLISHED TREATMENT OPTION FOR PATIENTS WITH INTRACTABLE DETRUSOR OVERACTIVITY AND NON-OBSTRUCTIVE URINARY RETENTION. THE SCOTTISH SACRAL NERVE STIMULATION SERVICE WAS ESTABLISHED IN APRIL 2010 TO PROVIDE A SERVICE FOR THE POPULATION OF SCOTLAND. WE REPORT OUR EXPERIENCE FROM THE FIRST YEAR OF THIS NEW NATIONAL SERVICE. ALL PATIENTS REFERRED FOR SNS FROM THE INCEPTION OF THE SERVICE IN APRIL 2010 UNTIL THE END OF MARCH 2011 WERE STUDIED. DURING THE ONE-YEAR PERIOD, THERE WERE 50 REFERRALS. THIRTY-THREE PERCUTANEOUS NERVE EVALUATIONS, EIGHT TINED LEAD TESTS AND 16 PERMANENT IMPLANTATION PROCEDURES WERE PERFORMED DURING THIS PERIOD. MORBIDITY WAS LOW AND BOTH INCONTINENCE AND QUALITY-OF-LIFE QUESTIONNAIRES DEMONSTRATED STATISTICALLY SIGNIFICANT IMPROVEMENTS (INTERNATIONAL CONSULTATION ON INCONTINENCE QUESTIONNAIRE [ICIQ-SF], P ¼ 0.005; INCONTINENCE IMPACT QUESTIONNAIRE [IIQ 7], P ¼ 0.0007; UROGENITAL DISTRESS INVENTORY [UDI 6], P ¼ 0.0002). REFERRAL PATTERN WAS SKEWED TOWARDS THE WEST OF SCOTLAND WITH SOME HEALTH BOARDS PRODUCING NO REFERRALS DURING THE YEAR. RESULTS FROM THE FIRST YEAR OF THE SERVICE HAVE SHOWN THAT IT IS A SAFE AND EFFICIENT PROCEDURE WITH SIGNIFICANT IMPROVEMENT IN INCONTINENCE, VOLUNTARY VOIDING AND QUALITY-OF-LIFE PARAMETERS. THE LIMITATION OF FUNDING FOR PERMANENT IMPLANTS INEVITABLY IMPACTS ON THE ROLE OF THE TECHNIQUE AS A MANAGEMENT OPTION IN THESE PATIENTS. REPORTED EVENT: 1 PATIENT EXPERIENCED AN INFECTION OF THE PERMANENT IMPLANT. ANTIBIOTICS WERE ADMINISTERED BUT THE INS AND LEAD WERE EXPLANTED. 1 PATIENT EXPERIENCED AN INFECTION OF THE TEST LEAD AND HAD EROSION OF THE LEAD THROUGH THE SKIN. THE LEAD WAS REMOVED. 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
    2112 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention