BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 7152056 · Received December 28, 2017

    Report

    Report Number
    3007566237-2017-05333
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LAGARES-TENA, L., MUNOZ-DUYOS, A. USE OF A NEW PLASMA SCALPEL DURING PULSE GENERATOR IMPLANT AND REPLACEMENT IN NEUROMODULATION. COGENT MEDICINE. 2017. 4: 1353248. DOI: 10.1080/2331205X.2017.1353248 SUMMARY: SACRAL NEUROMODULATION (SNM) IS A MINIMALLY INVASIVE THERAPY FOR DEFECATORY DISORDERS. PEAK PLASMA BLADE¿ (MEDTRONIC) HAS BEEN USED AS AN ALTERNATIVE TO THE CONVENTIONAL ELECTRIC SCALPEL AND SCISSORS IN 3 PROCEDURES OF NEUROMODULATION. PEAK PLASMABLADE¿ USES LESS TOTAL ENERGY, OPERATING AT SIGNIFICANTLY LOWER TEMPERATURES THAN ELECTROSURGICAL TECHNOLOGY. NO DAMAGE TO THE WIRES OR PULSE GENERATORS OR PATIENT COMPLICATIONS WERE DETECTED DURING THE SURGERY OR FOLLOW-UP. A REDUCTION IN THE DURATION OF THE PROCEDURES WAS NOTED. REPORTED EVENTS: A (B)(6) WOMAN WAS DIAGNOSED WITH SEVERE NEUROLOGIC FECAL INCONTINENCE. THE PATIENT WAS IMPLANTED AFTER A SUCCESSFUL TINED LEAD TEST IN 2010 IN THE LEFT S3 NERVE ROOT. AFTER FIVE YEARS, THE PATIENT REFERRED A RELAPSE IN HER SYMPTOMS. LOW BATTERY LEVEL WAS DETECTED AND A PG EXCHANGE WAS PERFORMED. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930913 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention