BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ENHANCED

    MDR report key: 7802707 · Received August 21, 2018

    Report

    Report Number
    3007566237-2018-02489
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 27, 2018
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 041829, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 305901, LOT# 60123087, PRODUCT TYPE: SCREENING. DEVICE ANALYSIS: DEVICE EVALUATED BY MFR: ANALYSIS OF LEAD 305901. PNE TEST STIM LEAD (LOT# 60123087) AND NDL (B)(4) FORAMEN PARYLENE CTD 5.0 IN (LOT# UNKNOWN) FOUND THE {X} CONDUCTOR(S) WERE STRETCHED IN THE BODY OF THE LEAD; HOWEVER, ELECTRICAL TESTING DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS. DEVICE CODE C62962 NO LONGER APPLIES TO COMPLAINT FILE DEVICE CODE C63228 APPLIES TO NDL (B)(4) FORAMEN PARYLENE CTD 5.0IN (LOT# UNKNOWN) ONLY. DEVICE CODE C63248 APPLIES TO LEAD 305901 PNE TEST STIM LEAD (LOT# 60123087) ONLY. METHOD AND RESULT CODE APPLY TO LEAD (LOT#60123087) ONLY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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

    THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 305901, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2020, UDI#:(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR FOR URGE INCONTINENCE. IT WAS REPORTED THAT THE LEAD CONTINUED TO CATCH ON THE NEEDLE WHEN THE HEALTH CARE PROFESSIONAL WAS TRYING TO DEPLOY WHEN IT CAUSED THE LEAD TO UNCOIL. THE REP STATED THAT IT EVENTUALLY BENT AND PULLED ALL THE WAY OUT OF THE SKIN. IT WAS MENTIONED THAT THE STYLET WOULDN'T REMOVE AFTER BEING PULLED. IT WAS ALSO NOTED THAT THE LEAD WAS DAMAGED AND THEY GOT A NEW LEAD AND USED ANOTHER NEEDLE. ON (B)(6) THE PATIENT REPORTED THAT SHE WAS PRETTY WIPED OUT AFTER HER PROCEDURE. THE REP CONFIRMED THAT THE NEW LEAD WIRE WORKED CORRECTLY AND WAS LEFT IN THE PATIENT FOR A SUCCESSFUL TRIAL. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641766 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR