BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 7126578 · Received December 18, 2017

    Report

    Report Number
    3007566237-2017-05212
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    July 18, 2017
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INTERSTIM_INS, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. 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

    LU, P. L., KOPPEN, I. J. N., ORSAGH-YENTIS, D. K., LEONHART, K., AMBEBA, E. J. DEANS, K. J., MINNECI, P. C., TEICH, S. DIEFENBACHH, K. A., ALPERT, S. A., BENNINGA, M. A., YACOB, D., DI LORENZO, C. SACRAL NERVE STIMULATION FOR CONSTIPATION AND FECAL INCONTINENCE IN CHILDREN: LONG-TERM OUTCOMES, PATIENT BENEFIT, AND PARENT SATISFACTION. NEUROGASTROENTEROLOGY AND MOTILITY : THE OFFICIAL JOURNAL OF (B)(6). 2017. DOI: 10.1111/NMO.13184 SUMMARY: TO EVALUATE THE LONG-TERM EFFICACY OF SACRAL NERVE STIMULATION (SNS) IN CHILDREN WITH CONSTIPATION AND DESCRIBE PATIENT BENEFIT AND PARENT SATISFACTION. USING A PROSPECTIVE PATIENT REGISTRY, WE IDENTIFIED PATIENTS <(><<)>21 YEARS OLD WITH CONSTIPATION TREATED WITH SNS FOR >2 YEARS. WE COMPARED SYMPTOMS, MEDICAL TREATMENT, PEDSQL GASTROINTESTINAL SYMPTOM SCALE (GSS), FECAL INCONTINENCE QUALITY OF LIFE SCALE (FIQL), AND FECAL INCONTINENCE SEVERITY INDEX (FISI) BEFORE SNS AND AT FOLLOW-UP. WE CONTACTED PARENTS TO ADMINISTER THE GLASGOW CHILDREN¿S BENEFIT INVENTORY (GCBI) AND A PARENT SATISFACTION QUESTIONNAIRE. WE INCLUDED 25 CHILDREN (52% MALE, MEDIAN AGE 10 YEARS): 16 HAD FUNCTIONAL CONSTIPATION, SIX ANORECTAL MALFORMATION, TWO TETHERED SPINAL CORD, AND ONE HIRSCHSPRUNG¿S DISEASE. DEFECATION FREQUENCY DID NOT CHANGE AFTER SNSBUT PATIENTS REPORTING FECAL INCONTINENCE DECREASED FROM 72% TO 20% (P<(><<)>.01) AND URINARY INCONTINENCE DECREASED FROM 56% TO 28% (P=.04). PATIENTS USING LAXATIVES DECREASED FROM 64% TO 44% (NS) AND PATIENTS USING ANTEGRADE ENEMAS DECREASED FROM 48% TO 20% (P=.03). GSS, MOST FIQL DOMAINS, AND FISI WERE IMPROVED AT FOLLOW-UP. SIX (24%) PATIENTS HAD COMPLICATIONS REQUIRING FURTHER SURGERY. OF THE 16 PARENTS CONTACTED, 15 (94%) PARENTS INDICATED POSITIVE HEALTH-RELATED BENEFIT AND ALL WOULD RECOMMEND SNS TO OTHER FAMILIES. SACRAL NERVE STIMULATION IS A PROMISING AND DURABLE TREATMENT FOR CHILDREN WITH REFRACTORY CONSTIPATION, AND APPEARS PARTICULARLY EFFECTIVE IN DECREASING FECAL INCONTINENCE. ALTHOUGH A QUARTER OF PATIENTS EXPERIENCED COMPLICATIONS REQUIRING ADDITIONAL SURGERY, NEARLY ALL PARENTS REPORTED HEALTH-RELATED BENEFIT. FUTURE STUDIES TO IDENTIFY PREDICTORS OF TREATMENT RESPONSE AND COMPLICATIONS ARE NEEDED. REPORTED EVENTS: FOUR (4) PATIENTS DEVELOPED LOCAL INFECTION OF THE SUBCUTANEOUS POCKET CREATED FOR IMPLANTATION OF THE PULSE GENERATOR. ALL FOUR PATIENTS UNDERWENT REMOVAL AND SUBSEQUENT REPLACEMENT OF SNS. ONE PATIENT DEVELOPED A SECOND INFECTION REQUIRING A SECOND SNS REMOVAL. IN THIS PATIENT, SNS WAS NOT REPLACED AFTER IT WAS REMOVED FOR THE SECOND TIME. ONE PATIENT EXPERIENCED LEAD DISPLACEMENT AFTER THE FIRST STAGE PROCEDURE BUT PRIOR TO PERMANENT IMPLANTATION OF THE PULSE GENERATOR DURING THE SECOND STAGE. THE PATIENT THEREFORE NEEDED A SECOND PROCEDURE TO REPOSITION THE LEAD, AFTER WHICH THE PATIENT EXPERIENCED IMPROVEMENT IN BOTH CONSTIPATION AND URINARY SYMPTOMS. THIS PATIENT THEN UNDERWENT A THIRD PROCEDURE FOR PERMANENT IMPLANTATION OF THE PULSE GENERATOR. ONE PATIENT APPROXIMATELY 12 MONTHS AFTER SNS REPLACEMENT, THE PATIENT DEVELOPED BOTH WORSENED CONSTIPATION AND NOCTURNAL ENURESIS AND WAS FOUND TO HAVE A MALFUNCTIONING LEAD. THE UNDERWENT LEAD REVISION WITH SUBSEQUENT SYMPTOMATIC IMPROVEMENT. SHORTLY AFTER THE SECOND STAGE PROCEDURE, ONE PATIENT EXPERIENCED LOWER EXTREMITY NUMBNESS AND DISCOMFORT WITH SITTING. THIS PATIENT UNDERWENT REPOSITIONING OF THE SNS PULSE GENERATOR WITHIN A MONTH OF THE SECOND STAGE PROCEDURE WITH SUBSEQUENT RESOLUTION OF THE NUMBNESS AND DISCOMFORT. ONE PATIENT EXPERIENCED A RELAPSE OF SYMPTOMS REQUIRING FURTHER SURGICAL INTERVENTION. AFTER A BRIEF PERIOD OF IMPROVEMENT IN CONSTIPATION SYMPTOMS FOR THE 3 MONTHS FOLLOWING SNS INITIATION, THIS PATIENT¿S SYMPTOMS GRADUALLY RETURNED OVER THE FOLLOWING YEAR DESPITE SNS TREATMENT. THIS PATIENT SUBSEQUENTLY UNDERWENT PARTIAL COLECTOMY WITH COLORECTAL ANASTOMOSIS APPROXIMATELY 15 MONTHS AFTER SNS PLACEMENT. THIS PATIENT CONTINUES TO HAVE AN SNS IN PLACE BUT HAS HAD INFREQUENT STOOLS AND REGULAR FECAL INCONTINENCE AT FOLLOW-UP. THREE PARENTS REPORTED THAT SNS IMPROVED URINARY SYMPTOMS BUT NOT CONSTIPATION SYMPTOMS, RAISING THE POSSIBILITY THAT PARENTS OF CHILDREN WITH URINARY SYMPTOMS REPORTED GREATER PATIENT BENEFIT OR PARENT SATISFACTION BECAUSE OF IMPROVEMENT IN URINARY SYMPTOMS ALONE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904444 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R