BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 7327057 · Received March 9, 2018

    Report

    Report Number
    3007566237-2018-00714
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    August 5, 2017
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LAGARES-TENA, L., MILLAN-PAREDES, L., LAZARO-GARCIA, L., NAVARRO-LUNA, A., DELGADO-RIVILLA, S., MUNOZ-DUYOS, A. SACRAL NEUROMODULATION IN PATIENTS WITH CONGENITAL FAECAL INCONTINENCE. SPECIAL ISSUES AND REVIEW OF THE LITERATURE. TECH COLO PROCTOL. 2018. DOI: 10.100 7/S10151-017-1742-5. SUMMARY: THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE EFFECTIVENESS OF SACRAL NEUROMODULATION (SNM) AS A TREATMENT FOR CONGENITAL FAECAL INCONTINENCE (FI). A RETROSPECTIVE STUDY WAS CONDUCTED ON PATIENTS WITH CONGENITAL FI WHO HAD SNM SURGERY AT OUR INSTITUTION BETWEEN (B)(6) 2005 AND (B)(6) 2013. AN INITIAL PERCUTANEOUS NERVE EVALUATION WAS PERFORMED, AND PATIENTS WITH AN IMPROVEMENT OF MORE THAN 50% IN THEIR SYMPTOMS HAD PERMANENTLY IMPLANTS FOR SNM TREATMENT. THERE WERE 4 PATIENTS WHO RECEIVED A PERMANENT IMPLANT. MEAN DURATION OF FOLLOW-UP WAS 67.5 MONTHS (RANGE 45¿135 MONTHS). AT LAST FOLLOW-UP, 2 PATIENTS MAINTAINED SIGNIFICANT IMPROVEMENT WITH SNM, 1 WAS EXPLANTED AFTER 4 YEARS OF TREATMENT DUE TO INFECTION BUT REMAINED ASYMPTOMATIC AND SNM FAILED IN THE REMAINING PATIENT WHO WENT ON TO GRACILOPLASTY. SNM MAY BE OF VALUE FOR TREATING FI IN PATIENTS WITH ANORECTAL MALFORMATIONS. REPORTED EVENT: ONE (B)(6) MALE PATIENT (PATIENT 3) INITIALLY REPORTED AN IMPROVED DEFECATION REFLEX SENSATION AND STOOL CONSISTENCY. HOWEVER, FOLLOWING SURGERY RECTAL MUCOSAL PROLAPSE, SNM THERAPY WAS NOT EFFICIENT AND THE PATIENT WAS EXPLANTED AT 5 YEARS AND WENT ON TO HAVE DYNAMIC GRACILOPLASTY. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171284 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention