BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3702105 · Received March 26, 2014

    Report

    Report Number
    3007566237-2014-00820
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    November 6, 2013
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE. NEUROSTIMULATOR PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE. NEUROSTIMULATOR (B)(4).

    Description of Event or Problem · 1

    LOMBARDI, G., MUSCO, S., CELSO, M., DEL CORSO, F., DEL POPOLO, G. SACRAL NEUROMODULATION FOR NEUROGENIC NON-OBSTRUCTIVE URINARY RETENTION IN INCOMPLETE SPINAL CORD PATIENTS: A TEN-YEAR FOLLOW-UP SINGLE-CENTRE EXPERIENCE. SPINAL CORD. 2014:DOI:10.1038/SC.2013.155 SUMMARY: TO DETERMINE THE SUCCESS RATE OF PERCUTANEOUS FIRST STAGE OF SACRAL NEUROMODULATION (SNM) AND THE EFFICACY AND SAFETY OF PERMANENT SNM FOR INCOMPLETE SPINAL CORD LESION (SCL) PATIENTS SUFFERING FROM CHRONIC NEUROGENIC NON-OBSTRUCTIVE URINARY RETENTION (N-NOR). FROM JANUARY 2003 TO DECEMBER 2012, 85 INDIVIDUALS UNDERWENT THE PERCUTANEOUS FIRST STAGE OF SNM. SUBSEQUENTLY, ONLY RESPONDERS WHO REACHED A CONCOMITANT REDUCTION BY AT LEAST 50% OF VOLUME PER CATHETERIZATION AND IN THE NUMBER OF CATHETERIZATIONS PER DAY COMPARING THEIR 7-DAY VOIDING DIARIES AT BASELINE UNDERWENT PERMANENT SNM. FINAL FOLLOW-UP WAS CONDUCTED BY APRIL 2013. THIRTY-SIX INDIVIDUALS RESPONDED TO PERCUTANEOUS FIRST STAGE OF SNM. POST-SURGERY URODYNAMICS DOCUMENTED ALL PATIENTS EXPERIENCING FIRST SENSATION OF BLADDER FILLING. A STATISTICALLY SIGNIFICANT INCREASE IN QMAX ML PER SEC AND DECREASE IN POST-VOIDING RESIDUAL URINE PER ML WERE DOCUMENTED. (PO0.01). FIRST SENSATION OF BLADDER FILLING AT BASELINE REPRESENTED A STATISTICALLY SIGNIFICANT PARAMETER FOR THE SUCCESS OF THE FIRST STAGE SNM (PO0.05). ELEVEN OUT OF 34 PATIENTS AT FOLLOW-UPS WERE ¿INCONSTANT RESPONDERS¿ BECAUSE THEY RETURNED TO SIMILAR BASELINE VOIDING SYMPTOMS, BUT RESPONDED AGAIN WITH AN IMPLANT ON THE CONTROLATERAL S3 SACRAL ROOT. TWO FAILED TWICE AND RESPONDED ONCE AGAIN AFTER AN S4 SACRAL ROOT IMPLANT. ALL BUT ONE FAILURE OCCURRED MORE THAN 3 YEARS AFTER THE PREVIOUS IMPLANT. OTHER DRAWBACKS WERE RESOLVED TELEMETRICALLY. RESEARCH IS NEEDED TO INCREASE THE SUCCESS RATE OF THE FIRST STAGE SNM ON INCOMPLETE SCL PATIENTS WITH N-NOR. PERMANENT SNM IS HIGHLY EFFICACIOUS IN THE MEDIUM FOLLOW-UP. REPORTED EVENTS: 1. 2 PATIENTS WERE CONSIDERED ¿INCONSTANT RESPONDERS¿ AND EXPERIENCED ¿FAILURE¿ WHICH WAS DEFINED AS LESS THAN 50% REDUCTION IN VOLUME PER CATHETERIZATION PER ML AND NUMBER OF CATHETERIZATIONS PER DAY. THE REPORTER STATED THAT THE FAILURE WAS ATTRIBUTED TO THE DISPLACEMENT OF THE SACRAL ELECTROCATHETER. THE PATIENTS REPORTEDLY HAD THE SYSTEM EXPLANTED AND A NEW SYSTEM IMPLANTED. 2. THERE WERE 11 FAILURES IN LESS THAN 11 PATIENTS. IT WAS NOTED THAT ¿FAILURE¿ WAS DEFINED AS LESS THAN 50% REDUCTION IN VOLUME PER CATHETERIZATION PER ML AND NUMBER OF CATHETERIZATIONS PER DAY. IT WAS NOTED THAT MODIFYING THE PATIENTS¿ PARAMETER SETTINGS DID NOT IMPROVE THE VOIDING SYMPTOMS. THE REPORTER STATED THAT AT FIRST FAILURE, A NEW IMPLANT ON THE S3 CONTRALATERAL ROOT WAS INTRODUCED, WHEREAS AT THE SECOND FAILURE, A SACRAL S4 ROOT IMPLANT WAS CARRIED OUT. IT WAS NOTED THAT THE PREVIOUS SYSTEM WAS REMOVED AT THE TIME OF NEW IMPLANT. IT WAS NOTED THAT THE CAUSES FOR FAILURE WERE UNIDENTIFIED. THE REPORTER STATED THAT THE FACT THE IMPLANT ON A NEW ¿VIRGIN¿ SACRAL ROOT RESTORED VOIDING IMPROVEMENT FOR ALL PATIENTS SEEMED TO CONFIRM THE THEORY OF NERVE FATIGUE AS THE REASON FOR UNKNOWN CAUSES OF FAILURE. THE REPORTER STATED THAT ALL PATIENTS RESPONDED UP TO THE FINAL CHECK-UP. 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
    177278 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention