BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3260068 · Received August 1, 2013

    Report

    Report Number
    3007566237-2013-02553
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    January 8, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    LENIS, A. T., GILL, B. C., CARMEL, M. E., RAJKI, M., MOORE, C. K. ,VASAVADA, S. P., GOLDMAN, H. B., RACKLEY, R. R. PATTERNS OF HARDWARE RELATED ELECTRODE FAILURES IN SACRAL NERVE STIMULATION DEVICES. THE JOURNAL OF UROLOGY. 2013;190(1):175-179. DOI: 10.1016/J.JURO.2013.01.013. SUMMARY: ABNORMAL ELECTRICAL IMPEDANCE IN SACRAL NERVE STIMULATION DEVICES IS A CAUSE OF DEVICE FAILURE. CURRENTLY, THERE IS SCANT LITERATURE EVALUATING THE INCIDENCE AND MANAGEMENT OF THIS PROBLEM. WE EVALUATED THE PRESENTATION, CHARACTERISTICS AND MANAGEMENT OF SACRAL NERVE STIMULATION DEVICES WITH ABNORMAL ELECTRICAL IMPEDANCE. A TOTAL OF 565 PATIENTS WERE PERMANENTLY IMPLANTED WITH SACRAL NERVE STIMULATION DEVICES USING A TINED LEAD BETWEEN 2003 AND 2011. DEVICES WERE INTERROGATED POSTOPERATIVELY AND AT FOLLOWUP. ABNORMAL ELECTRICAL IMPEDANCE WAS CLASSIFIED AS OPEN CIRCUIT¿IMPEDANCE GREATER THAN 4,000 - OR SHORT CIRCUIT¿IMPEDANCE LESS THAN 50 - AND/OR EQUIVALENCE OF IMPEDANCE. DETAILS ON PRESENTATION, CHARACTERISTICS AND MANAGEMENT WERE RECORDED. OF THE 565 PATIENTS 72 (12.7%) EXPERIENCED A TOTAL OF 86 ABNORMAL ELECTRICAL IMPEDANCE EVENTS, OF WHICH 57 (66.2%) WERE OPEN CIRCUITS AND 28 (32.5%) WERE SHORT CIRCUITS. ONE EVENT (1.1%) WAS A SIMULTANEOUS OPEN AND SHORT CIRCUIT. SHORT CIRCUITS PRESENTED EARLIER THAN OPEN CIRCUITS (MEDIAN 3.5 MONTHS, IQR 2¿7.5 VS 15, IQR 5.5¿30.5, P _0.0001) AND REQUIRED SURGICAL INTERVENTION MORE OFTEN (75.0% VS 54.3%, P _ 0.09). PATIENT SPECIFIC FACTORS, SUCH AS TRAUMA HISTORY AND CHANGE IN BODY MASS INDEX CLASS, WERE NOT ASSOCIATED WITH ABNORMAL ELECTRICAL IMPEDANCE. NO ELECTRODE FAILURE PATTERNS COULD BE IDENTIFIED. ABNORMAL ELECTRICAL IMPEDANCE OCCURRED IN APPROXIMATELY 13% OFCASES PERMANENTLY IMPLANTED IN OUR SERIES. SHORT CIRCUITS PRESENTED EARLIER AND OFTEN REQUIRED SURGICAL INTERVENTION. OPEN CIRCUITS PRESENTED LATER AND MAY HAVE POTENTIALLY BEEN SECONDARY TO MICROFRACTURES THAT ACCUMULATE WITH TIME AT THE SACRAL PLATE, RESULTING IN LATER PRESENTATION. ALMOST A THIRD OF PATIENTS WITH ABNORMAL ELECTRICAL IMPEDANCE ASSOCIATED WITH CLINICAL INEFFICACY WERE TREATED CONSERVATIVELY, PRIMARILY WITH REPROGRAMMING. REPORTED EVENT: 1 FEMALE PATIENT HAD SIMULTANEOUS SHORT AND OPEN CIRCUIT FAILURES WHICH PRESENTED 19 MONTHS AFTER PERMANENT IMPLANTATION. A SURGICAL REVISION WAS DONE. 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
    360911 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention