BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5112443 · Received September 29, 2015

    Report

    Report Number
    3007566237-2015-02767
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    February 10, 2015
    Report Date
    September 2, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE EVENT OF COLON PERFORATION WAS NOT RELATED TO THE DEVICE OR THERAPY, BUT INSTEAD REL ATED TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS. THEREFORE, ONLY THE FOLLOWING. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. THE DEVICE WAS USED IN AN OFF-LABEL MANNER. CONCOMITANT: PRODUCT ID 4351, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4)

    Description of Event or Problem · 1

    ISBERT, C., SCHLEGEL, N., REIBETANZ, J., KRAJINOVIC, K., SCHMIDT, K., GERMER, C-T., KIM, M. NEUROSTIMULATED LEVATOR AUGMENTATION--A NEW APPROACH IN RESTORING CONTINENCE. INT. J. COLORECTAL DIS. 2015;30(4):505-512. DOI 10.1007/S00384-015-2134-9. SUMMARY: RESTORATION OF CONTINENCE REMAINS A MAJOR CHALLENGE IN PATIENTS AFTER ABDOMINOPERINEAL RECTAL EXCISION (APE) OR WITH END-STAGE FECAL INCONTINENCE. A NEW SURGICAL TECHNIQUE, THE NEUROSTIMULATED LEVATOR AUGMENTATION, WAS INTRODUCED FOR PELVIC FLOOR AUGMENTATION USING DYNAMIC GRACILOPLASTY IN ORDER TO RESTORE ANORECTAL ANGULATION. THE AIM OF THIS STUDY WAS TO ASSESS FEASIBILITY AND EFFICIENCY. FROM NOVEMBER 2009 TO MARCH 2014, N=17 PATIENTS UNDERWENT NEUROSTIMULATED LEVATOR AUGMENTATION (N= 10 AFTER APE, N=5 INTRACTABLE IDIOPATHIC FECAL INCONTINENCE, N=2 TRAUMATIC ANAL AMPUTATION). GRACILIS MUSCLE WAS TRANSPOSED THROUGH THE OBTURATOR FORAMEN INTO THE PELVIC CAVITY, POSITIONED IN A U-SHAPED SLING BEHIND THE RECTUM, FIXED TO THE CONTRALATERAL OS PUBIS TO RESTORE ANORECTAL ANGULATION, AND THEN CONDITIONED BY NEUROSTIMULATION. QUESTIONNAIRES ANALYZING FUNCTION AND QUALITY OF LIFE WERE ADMINISTERED. FOR NEUROSTIMULATED LEVATOR AUGMENTATION, FOUR PATIENTS SUFFERED FROM COMPLICATIONS THAT NEEDED OPERATIVE INTERVENTION (N=3 WOUND INFECTION, N=1 COLON PERFORATION); THREE PHARMACOLOGICAL TREATMENT AND TWO COMPLICATIONS NEEDED NO FURTHER INVASIVE INTERVENTION. ONE PATIENT DIED DUE TO CAUSES UNRELATED TO THE OPERATION, AND NO COMPLICATION REQUIRED INTENSIVE CARE MANAGEMENT. FECAL INCONTINENCE IN PATIENTS WITH IDIOPATHIC INCONTINENCE IMPROVED SIGNIFICANTLY AFTER SURGERY AS WELL AS INCONTINENCE EPISODES, URGENCY, AND DISEASESPECIFIC QUALITY OF LIFE THROUGH ALL DIMENSIONS. GENERIC QUALITY OF LIFE WAS SIGNIFICANTLY BETTER AFTER SURGERY IN ALL PATIENTS. AFTER MEDIAN FOLLOW-UP OF 17 MONTHS (2-45), ALL BUT ONE PATIENT WOULD UNDERGO THE PROCEDURE AGAIN. NEUROSTIMULATED LEVATOR AUGMENTATION WAS FEASIBLE IN ALL PATIENTS WITH ACCEPTABLE MORBIDITY. IT MAY REPRESENT A NEW THERAPEUTIC OPTION IN SELECTED PATIENTS WITH INTRACTABLE FECAL INCONTINENCE. REPORTED EVENTS: 1 FEMALE PATIENT WITH FECAL INCONTINENCE DUE TO RECURRENT ANAL CANCER SUFFERED FROM COLON PERFORATION THAT NEEDED OPERATIVE INTERVENTION. THE COLON PERFORATION OCCURRED AFTER USE OF ANAL IRRIGATION ONE MONTH AFTER STOMA CLOSURE AND SEVEN MONTHS AFTER COMPLETE PERINEAL RECONSTRUCTION WITH SIMULTANEOUS NEUROSTIMULATED LEVATOR AUGMENTATION (NLA). THE PERFORATION WAS OVERSTITCHED AND A PROTECTIVE ILEOSTOMY CREATED. THE PATIENT REFUSED CLOSURE OF THE STOMA AT THE TIME OF ARTICLE PUBLICATION. 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
    643304 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3023 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Life Threatening| R