BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

    MDR report key: 6058741 · Received October 26, 2016

    Report

    Report Number
    3007566237-2016-03735
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    May 1, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE¿S ¿GROUP A¿ AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE 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_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BEER, G.M., GURULE, M.M., KOMESU, Y.M., QUALLS, C.R., ROGERS, R.G. CYCLING VERSUS CONTINUOUS MODE IN NEUROMODULATOR PROGRAMMING: A CROSSOVER, RANDOMIZED, CONTROLLED TRIAL. UROL. NURS. 2016; 36(3):123-132. DOI:(B)(4) SUMMARY: THIS IS A RANDOMIZED, CONTROLLED, BLIND, CROSSOVER TRIAL COMPARING CYCLING VERSUS CONTINUOUS PROGRAMMING OF A SACRAL NEUROMODULATOR IN WOMEN DIAGNOSED WITH OVERACTIVE BLADDER (OAB). REPORTED EVENTS OF GROUP A (N=11, AVG AGE = 69.8): FOUR FEMALE PATIENTS WITH SACRAL NERVE STIMULATION (SNS) FOR OVERACTIVE BLADDER (OAB) UNDERWENT AN ADDITIONAL SURGERY WITHIN THE FIRST 6 MONTHS AFTER IMPLANTABLE NEUROSTIMULATOR (INS) PLACEMENT, BUT WHAT PROMPTED THESE SURGERIES WAS NOT STATED. ONE FEMALE PATIENT WITH SNS FOR OAB EXPERIENCED A URINARY TRACT INFECTION (UTI) BETWEEN 3 AND 6 MONTHS POST-IMPLANT. THIS PATIENT WAS ON ANTIBIOTICS AT THE TIME OF ARTICLE PUBLICATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707637 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention