BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5549798 · Received April 6, 2016

    Report

    Report Number
    3007566237-2016-01597
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    December 8, 2015
    Report Date
    April 6, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS PAIN RELIEF. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM FROM THE FIRST EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD .

    Description of Event or Problem · 1

    GUARDO L. A, GALA, C. C., POVEDA, D. S., JUAN, P. R, MONTERO, F. J. S., SNCHEZ, J. C. G., LAMAS, J. I. S., HERNANDEZ, M. V. S. CAUDAL NEUROMODULATION WITH THE TRANSFORAMINAL SACRAL ELECTRODE (INTERSTIM(R)): EXPERIENCE IN A PAIN CENTER REGARDING 12 IMPLANTS. THE (B)(6)JOURNAL OF PAIN. 2016; 29(1): 23-28. DOI: 10.3344/KJP.2016.29.1.23 SUMMARY: SACRAL NERVE STIMULATION IS A THERAPEUTIC OPTION WITH DEMONSTRATED EFFICACY FOR CONDITIONS PRESENTING WITH PERINEAL PAIN CAUSED BY DIFFERENT ETIOLOGIES. WE AIMED TO ASSESS WHETHER A SACRAL ELECTRODE ((B)(4)) INSERTED THROUGH THE CAUDAL PATHWAY IS ABLE TO OFFER AN ACCEPTABLE LEVEL OF SACRAL STIMULATION AND RATE OF CATHETER MIGRATION. WE PRESENT 12 PATIENTS WITH PELVIC PAIN WHO RECEIVED SACRAL NEUROMODULATION VIA THE SACRAL HIATUS WITH THE INTERSTIM ELECTRODE. WE EVALUATED PATIENT SATISFACTION AS WELL AS MIGRATION AND REMOVAL OF THE ELECTRODE, IF NECESSARY. OUR EXPERIENCE INCLUDED 12 PATIENTS, 10 WOMEN AND TWO MEN, WITH A MEAN AGE OF 60 YEARS. IN EIGHT OF THE 12 PATIENTS, THE INITIAL THERAPY WAS EFFECTIVE, AND THE FINAL SYSTEM IMPLANTATION WAS PERFORMED. DURING SUBSEQUENT FOLLOW-UP, PATIENT SATISFACTION WAS GOOD. TO DATE, THERE HAVE BEEN NO CASES OF ELECTRODE DISPLACEMENT OR MIGRATION. THE CAUDAL INSERTION OF THE INTERSTIM ELECTRODE, WITH ITS OWN FIXATION SYSTEM, AND INITIALLY DESIGNED FOR TRANSSACRAL INSERTION, APPEARS IN OUR EXPERIENCE TO BE A SATISFACTORY OPTION WHICH CAN MINIMIZE ELECTRODE DISPLACEMENTS, ACHIEVING SIMILAR RESULTS IN THERAPEUTIC EFFICACY AND CAUSING NO DIFFICULTIES IN REMOVAL. REPORTED EVENTS: ONE INTERSTITIAL CYSTITIS PATIENT EXPERIENCED A "SLIGHT DISPLACEMENT" OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE ISSUE MADE IT "NECESSARY TO REVISE THE SITE AND REPLACE THE GENERATOR." IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A DECREASED SUBJECTIVE IMPROVEMENT FROM THEIR PAIN THERAPY FROM 85% AS OF 6 MONTHS AFTER IMPLANT TO 70% AT BOTH 12 AND 24 MONTHS AFTER IMPLANT. AN UNKNOWN NUMBER OF PATIENTS WHO WERE IMPLANTED WITH ANTEROGRADE ELECTRODES VIA A CAUDAL APPROACH EXPERIENCED "CATHETER MOVEMENT AND THEREFORE TREATMENT FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208849 INTERSTIM IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention