BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 10168628 · Received June 18, 2020

    Report

    Report Number
    3010291427-2020-00008
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 27, 2020
    Manufacturer
    AVAILMED S.A.DE C.V.9
    Product Code
    EZW
    UDI-DI
    00763000114077
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID: 041838; PRODUCT TYPE: ACCESSORY; PRODUCT ID: NEU_STYLET_ACC; PRODUCT TYPE: ACCESSORY; H3: ANALYSIS OF THE LEAD LOT NO: 60215811 FOUND THAT 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. H3: ANALYSIS OF THE STYLET WITH UNKNOWN SERIAL NUMBER FOUND THAT THE ANALYSIS IDENTIFIED THAT THE STYLET WIRE WAS BENT {X} CM FROM THE {DISTAL / PROXIMAL} END. 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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED, ANALYSIS NOT YET COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEU ROSTIMULATOR (ENS). THE REP REPORTED THE LEAD GOT STUCK INSIDE THE FORAMEN NEEDLE DURING THE END OF THE PROCEDURE AS THE NEEDLE WAS BEING REMOVED AFTER LEAD PLACEMENT. THERE WERE NO CONTRIBUTING FACTORS OR DIAGNOSTICS/TROUBLESHOOTING PERFORMED. THE LEAD WAS REMOVED AND THE PNE PROCEDURE ON THE LEFT SIDE WAS STARTED OVER. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE REP WAS ASKED TO EXPLAIN WHERE ON THE NEEDLE THE LEAD GOT STUCK AND THEY SAID RIGHT AT THE PROXIMAL END, JUST AS THE PROXIMAL END WAS ENTERING THE PROXIMAL END OF THE NEEDLE. THEY WERE ASKED IF THEY HAD ANY THOUGHTS ON THE CAUSE OF IT GETTING STUCK AND THEY SAID THEY DIDN'T HAVE ANY THOUGHTS, THEY SAID THAT EVERYTHING WAS TEXTBOOK. THEY DOCTOR HAD REMOVED THE BLUE RUBBER AND WHEN THEY WENT TO SLIDE THE STYLET, IT JUST JAMMED. EVERYTHING WAS INSIDE THE NEEDLE, THE DOCTOR TRIED TO PUSH IT THROUGH/PULLED ON IT HARD, THEY FINALLY PULLED ENOUGH TO STRETCH THE LEAD, SO THEY DECIDED TO GRAB A NEW ONE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634511 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AVAILMED S.A.DE C.V.9 306001 60215811 00763000114077

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR