BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 8838685 · Received July 29, 2019

    Report

    Report Number
    3007566237-2019-01667
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 2, 2019
    Report Date
    October 27, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 309101 LOT# HG32T93, PRODUCT TYPE SCREENING DEVICE PRODUCT ID 309101 LOT# HG32PJA PRODUCT TYPE SCREENING DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT(S): PRODUCT ID: 309101, LOT# HG32T93, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 309101, LOT# HG32PJA, PRODUCT TYPE: SCREENING DEVICE. UPDATED TO EZW AS THE LEAD KIT IS REPORTABLE AND IMPLANTABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 309101, LOT#: HG32T93, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 309101, LOT#: HG32PJA, PRODUCT TYPE: SCREENING DEVICE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 309101, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER REPORTED VIA MANUFACTURE REPRESENTATIVE THAT DURING THE TRIAL THEY TRIED TO REMOVE THE STYLET BUT FOUND MECHANICAL RESISTANCE AND IN ORDER TO EXTRACT IT, THEY PULLED IT HARDER AND THE STYLET BROKE. THE PHYSICIAN DISCARDED THE STYLET AND THE NEEDLE. IT WAS NOTED THAT THEY HAD THE SAME PROBLEM IN THE SAME DAY WITH ANOTHER STYLET. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE 2 BROKEN STYLETS OCCURRED IN 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630795 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1