BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3766849 · Received April 23, 2014

    Report

    Report Number
    3007566237-2014-01113
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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 PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    SHARIFIAGHDAS, F., MIRZAEI, M., AHADI, B. PERCUTANEOUS NERVE EVALUATION (PNE) FOR TREATMENT OF NON-OBSTRUCTIVE URINARY RETENTION: URODYNAMIC CHANGES, PLACEBO EFFECTS, AND RESPONSE RATES. UROLOGY JOURNAL. 2014;11(1):1301-1307. SUMMARY: TO EVALUATE THE RESULTS OF PERCUTANEOUS NERVE EVALUATION (PNE) IMPLANTATION IN THE TREATMENT OF NON-OBSTRUCTIVE URINARY RETENTION AND REPORT THE CHANGES IN THE URODYNAMIC PARAMETERS. PATIENTS WITH NON-OBSTRUCTIVE URINARY RETENTION OR INCOMPLETE BLADDER EMPTYING WERE INCLUDED. ALL PATIENTS FILLED A 7 DAYS VOIDING DIARY CHART AND UNDERWENT PNE FOR ONE WEEK, AND THE PATIENT WAS ASKED TO RECORD THE SECOND VOIDING DIARY CHART AND REPEAT URODYNAMIC STUDY IN THIS PERIOD. THEN THE PNE LEAD WAS REMOVED FROM THE S3 FORAMEN, BUT THE CONNECTIONS REMAINED FIXED IN PLACE FOR ANOTHER 3 DAYS TO EXCLUDE THE PLACEBO EFFECTS AND THE THIRD VOIDING DIARY CHART WAS COMPLETED BY THE PATIENT. THE PATIENT WASN¿T AWARE OF LEAD REMOVAL. SUCCESS WAS DEFINED AS, MORE THAN 50% IMPROVEMENT IN AT LEAST ONE OF THE URINARY TRACT SYMPTOMS. FORTY FIVE PATIENTS WITH A MEAN AGE OF 37.1 YEARS (RANGED 9-83 YEARS) WERE TREATED WITH PNE FOR REFRACTORY, NON-OBSTRUCTIVE URINARY RETENTION. OF STUDY SUBJECTS 28 COMPLAINED FROM COMPLETE URINARY RETENTION, AND 17 HAD INCOMPLETE EMPTYING. OF PARTICIPANTS, 28 (62.2%) DEMONSTRATED GREATER THAN 50% IMPROVEMENT IN THE URINARY SYMPTOMS. URODYNAMIC DATA, SHOWED A STATISTICALLY SIGNIFICANT INCREASE IN MAXIMUM FLOW RATE (8 ± 2.2 ML/SEC TO 16 ± 3.6 ML/SEC, P = .06) AND VOIDED VOLUME (35 ML TO 187 ML, P = .032) IN THE RESPONDERS. ANY PLACEBO EFFECTS IN PNE HAVE NOT BEEN SEEN. PATIENTS WITH COMPLETE NON OBSTRUCTIVE URINARY RETENTION WERE GOOD RESPONDERS TO PNE. THE PLACEBO EFFECT IN SACRAL NERVE STIMULATION WAS NEGLIGIBLE. REPORTED EVENTS: 1 PATIENT WITH NON-OBSTRUCTIVE URINARY RETENTION EXPERIENCED AN INFECTION DURING THE PERCUTANEOUS NERVE EVALUATION (PNE). 2 PATIENTS WITH NON-OBSTRUCTIVE URINARY RETENTION HAD LEAD MIGRATION DURING THE PNE. 1 PATIENT WITH NON-OBSTRUCTIVE URINARY RETENTION EXPERIENCED AN ELECTRICAL SHOCKING SENSATION DURING THE PNE. 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
    247034 EXTERNAL NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention