BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6090378 · Received November 9, 2016

    Report

    Report Number
    3007566237-2016-03997
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    August 19, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    HOAG, N., PLAGAKIS, S., PILLAY, S., EDWARDS, A.W., GANI, J. SACRAL NEUROMODULATION FOR REFRACTORY OVERACTIVE BLADDER AFTER PRIOR IN TRAVESICAL ONABOTULINUMTOXINA TREATMENT. NEUROUROL. URODYN. 2016. 9999 (1-5). DOI: 10.1002/NAU.23117 SUMMARY: SACRAL NEUROMODULATION (SNM) IS A WELL-ESTABLISHED TREATMENT MODALITY FOR REFRACTORY OVERACTIVE BLADDER (OAB). THERE IS A PAUCITY OF EVIDENCE EXAMINING THE USE OF SNM IN PATIENTS WHO HAVE RECEIVED PRIOR INTRAVESICAL ONABOTULINUMTOXINA (BTXA) TREATMENT. WE AIM TO REVIEW THOSE PATIENTS WHO UNDERWENT SNM FOR REFRACTORY OAB FOLLOWING TREATMENT WITH BTXA. REPORTED EVENTS FOR PRIOR BTXA COHORT (MEAN AGE: 60 YEARS, MAJORITY FEMALE). ONE PATIENT WITH SACRAL NEUROMODULATION (SNM) FOR OVERACTIVE BLADDER (OAB) FOLLOWING DISCONTINUATION OF ONABOTULINUMTOXINA (BTXA) TREATMENT EXPERIENCED ANAPHYLACTIC-TYPE REACTION POSTOPERATIVELY. IT WAS UNKNOWN IF BTXA WAS A CAUSATIVE ETIOLOGY FOR THIS EVENT. THREE PATIENTS WITH SACRAL NEUROMODULATION (SNM) FOR OVERACTIVE BLADDER (OAB) FOLLOWING DISCONTINUATION OF ONABOTULINUMTOXINA (BTXA) TREATMENT REQUIRED SURGICAL REVISION PROCEDURES. THE REASONS FOR REVISION WERE NOT PROVIDED. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739397 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R