BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3242811 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02449
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    December 30, 2010
    Report Date
    October 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    DUELUND-JAKOBSEN, J., LUNDBY, L., FASSOV, J., ROSENKILDE, M., BUNTZEN, S., LAURBERG, S. RETROPERITONEAL AIR AFTER PERCUTANEOUS NERVE EVALUATION FOR IRRITABLE BOWEL SYNDROME. INTERNATIONAL JOURNAL OF COLORECTAL DISEASE. 2011;26(9):1225-1226. DOI: 10.1007/S00384-010-1110-7. SUMMARY: A (B)(6) MAN WITH LIFELONG IBS WAS REFERRED TO THE DEPARTMENT OF ANAL PHYSIOLOGY, (B)(6) HOSPITAL, (B)(6), FOR EVALUATION IN (B)(6) 2009. IN (B)(6) 2009, THE PATIENT WAS ACCEPTED FOR A PNE TEST PERFORMED UNDER GENERAL ANESTHESIA, IN WHICH TEST NEEDLES WERE USED. TEMPORARY PERCUTANEOUS ELECTRODES (MEDTRONIC INTERSTIM®, MODEL 3057; MINNEAPOLIS, MN) WERE INSERTED IN THE SACRAL FORAMEN (S3/S4, BILATERALLY), BASED ON THE BEST MOTOR RESPONSE. THE PATIENT WAS STIMULATED AT THE LEFT S4 ELECTRODE SITE (AMPLITUDE, 2 V; FREQUENCY, 14 HZ; AND PULSE WIDTH, 210 ¿S) FOR A 3-WEEK PERIOD. DURING THE TEST PERIOD, THE PATIENT FILLED IN A BOWEL HABIT DIARY, GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS-IBS), AND IBS IMPACT SCALE (IBS-IS) ON A WEEKLY BASIS. THE MULTI-SLICE COMPUTERIZED TOMOGRAPHY MSCT SCAN SHOWED SMALL POCKETS OF RETROPERITONEAL AIR PRE-SACRALLY. WE CONCLUDED THAT THE RETROPERITONEAL AIR WAS DUE TO A TEST NEEDLE PERFORATING THE RECTUM. THE PATIENT WAS CONTACTED AND INFORMED ABOUT THE FINDINGS. HE WAS FEELING VERY WELL AND HAD NO SIGNS OF FEVER OR ABDOMINAL PAIN 48 H POSTOPERATIVELY. AS A SAFETY PRECAUTION, THE PATIENT WAS TREATED WITH ANTIBIOTICS ADMINISTERED PERORALLY FOR ONE WEEK. REPORTED EVENT: A (B)(6) MALE EXPERIENCED SMALL POCKETS OF RETROPERITONEAL AIR PRESACRALLY FOLLOWING PERCUTANEOUS NERVE EVALUATION, AS SHOWN BY MULTI-SLICE COMPUTERIZED TOMOGRAPHY (MSCT). THE RETROPERITONEAL AIR WAS DUE TO A TEST NEEDLE PERFORATING THE RECTUM. THE PATIENT WAS FEELING WELL AND HAD NO SIGNS OF FEVER OR ABDOMINAL PAIN 48 HOURS POST-OPERATIVELY. AS A SAFETY PRECAUTION, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR ONE WEEK. THE PATIENT FELT WELL AND SHOWED NO ABDOMINAL PAIN OR FEVER DURING THE TEST PERIOD. THE PATIENT WAS SATISFIED WITH THEIR RESULTS AND WENT ON TO PERMANENT IMPLANT. 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
    342403 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Required Intervention