BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3182937 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02055
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3058, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3058, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3058, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3889-28, LOT# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3889-28, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SCHWANDNER, O. SACRAL NEUROMODULATION FOR FECAL INCONTINENCE AND "LOW ANTERIORRESECTION SYNDROME" FOLLOWING NEOADJUVANT THERAPY FOR RECTAL CANCER. INTERNATIONAL JOURNAL OF COLORECTAL DISEASE ( INT. J. COLORECTALDIS. ). 2013;J(5):665-669. DOI:10.1007/S00384-013-1687-8 SUMMARY: IT WAS THE AIM OF THIS PROSPECTIVE STUDY TO ANALYZE BOTH FEASIBILITY AND EFFECTIVENESS OF SACRAL NEUROMODULATION FOR FECAL INCONTINENCE AND ¿LOW ANTERIOR RESECTION SYNDROME¿ FOLLOWING NEOADJUVANT THERAPY FOR RECTAL CANCER. ALL PATIENTS WHO UNDERWENT SACRAL NEUROMODULATION FOLLOWING NEOADJUVANT THERAPY FOR RECTAL CANCER (PREOPERATIVE RADIOCHEMOTHERAPY, ONCOLOGIC RECTAL RESECTION WITH TOTAL MESORECTAL EXCISION) WERE PROSPECTIVELY ENROLLED IN THE STUDY. ONLY PATIENTS WITH FAILURE OF CONSERVATIVE TREATMENT AND WITHOUT ANY EVIDENCE OF RESIDUAL OR RECURRENT TUMOR DISEASE WERE CANDIDATES FOR SACRAL NEUROMODULATION WHICH WAS PERFORMED BY A TWO-STAGE PROCEDURE (DIAGNOSTIC PERCUTANEOUS TEST STIMULATION FOLLOWED BY DEFINITE IMPLANT). IN ADDITION TO FEASIBILITY, PRIMARY END POINTS INCLUDED SUCCESS (REDUCTION OF INCONTINENT EPISODES), CONTINENCE AND DEFECATION STATUS (ASSESSED BY CLEVELAND CLINIC INCONTINENCE SCORE AND ALTOMARE SCORE), AND QUALITY OF LIFE (EQ-5D). ANAL MANOMETRY WAS PERFORMED PREOPERATIVE AND AT 12-MONTH FOLLOW-UP. FOLLOW-UP INFORMATION WAS DERIVED FROM CLINICAL EXAMINATION 3, 6, AND 12 MONTHS POSTOPERATIVELY. NINE PATIENTS (THREE FEMALES, SIX MALES) WITH A MEAN AGE OF (B)(6) UNDERWENT SACRAL NEUROMODULATION FOLLOWING NEOADJUVANT THERAPY FOR RECTAL CANCER. IMPLANTATION RATE WAS 100 %. NO SEPTIC MORBIDITY WAS OBSERVED. AFTER A MEAN FOLLOW-UP OF 12 MONTHS, MEAN CLEVELAND CLINIC INCONTINENCE SCORE WAS REDUCED FROM 18.2 TO 6.0 (P<(><<)>0.01). INCONTINENCE EPISODES WERE SIGNIFICANTLY REDUCED FROM 7 TO 0.5 (PER DAY) AND 20 TO 8 (PER WEEK). FECAL URGENCY, FRAGMENTED DEFECATION, AND SOILING WERE IMPROVED OR RESOLVED IN TWO THIRDS. ALTOMARE SCORE WAS SIGNIFICANTLY REDUCED FROM 21.0 TO 9.3 (P<(> <<)>0.01). ANORECTAL MANOMETRY DID NOT CORRELATE WITH CLINICAL SUCCESS. QUALITY OF LIFE WAS SIGNIFICANTLY IMPROVED (EQ-5D GENERIC: 0.42 VS. 0.74, EQ-5D-VAS SCORE: 20 VS. 90, P<(><<)>0.01). PRELIMINARY RESULTS OF SACRAL NEUROMODULATION IN PATIENTS WITH FECAL INCONTINENCE AND SYMPTOMS OF ¿LOW ANTERIOR RESECTION SYNDROME¿ ARE PROMISING AND ENRICH THE THERAPEUTIC MODALITIES IF CONSERVATIVE MANAGEMENT HAS FAILED. REPORTED EVENTS: ONE PATIENT HAD IATROGENIC RUPTURE OF THE TINED LEAD REQUIRING REMOVAL AND TRANSSACRAL REPLACEMENT DURING PERMANENT IMPLANTATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284152 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention