BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 11381979 · Received February 25, 2021

    Report

    Report Number
    2649622-2021-03740
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    May 3, 2021
    Manufacturer
    MPRI
    Product Code
    EZW
    UDI-DI
    00763000203726
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE FORAMEN NEEDLE IDENTIFIED A PROCEDURAL NON-CONFORMANCE OF DAMAGE TO THE PARYLENE COATING OF THE CANNULA. ANALYSIS OF THE DILATOR FOUND THAT THE DEVICE PASSED ALL TESTING IN THE LABORATORY AND NO ANOMALIES WERE IDENTIFIED. 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 PRODUCTS: PRODUCT ID: 041838, LOT#: UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_PNENEEDLE_ACC, LOT#: UNKNOWN, PRODUCT TYPE: ACCESSORY. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 041838, LOT#: UNKNOWN, PRODUCT TYPE: ACCESSORY, UBD: UNKN, UDI#:UNKN. NEU_PNENEEDLE_ACC, LOT#: UNKNOWN, PRODUCT TYPE: ACCESSORY, UBD: UNKN, UDI#:UNKN. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A LEAD. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE FORAMEN NEEDLE TO LOCATE THE S3 FORAMEN AND KEPT FEELING BONE. THEY TRIED ADVANCING THE NEEDLE, ENCOUNTERED A LOT OF BONE AND HAD TROUBLE ADVANCING THE NEEDLE. WHEN THEY REMOVED THE NEEDLE THEY NOTICED SOMETHING ATTACHED TO THE NEEDLE. THEY GAVE IT BACK TO THE SCRUB TECH AND REQUESTED THE OTHER NEEDLE THAT WAS ON THE FIELD. AFTER FURTHER EVALUATION IT LOOKED AS THOUGH A COATING WAS COMING OFF THE NEEDLE. IT SEEMED THAT THE NEEDLE SCRAPED ON THE BONE AND MAY HAVE STARTED TO PULL THE COATING ON THE FORAMEN NEEDLE, SO IT WAS NO LONGER USED. ADDITIONAL DETAIL WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE REP (B)(6) 2021: THE CAUSE OF THE COATING COMING OFF THE NEEDLE WAS DETERMINED TO BE DUE TO SCRAPING ON THE BONE DUE TO PHYSICIAN TRYING TO ADVANCE THE NEEDLE AND GETTING RESISTANCE FROM THE BONE, THE BONE DAMAGED THE NEEDLE. ADDITIONALLY, WHEN THEY WENT TO REMOVE THE STYLET THE PHYSICIAN HAD TROUBLE INITIALLY. THEY TRIED PULLING ON THE PLASTIC PIECE AT THE TOP OF THE STYLET AND THE PLASTIC PIECE SEPARATED FROM THE STYLET. THE PHYSICIAN WAS ABLE TO REMOVE THE STYLET FROM THE INTRODUCER SHEATH USING AN INSTRUMENT AND THEN PROCEED WITH THE PROCEDURE TO RESOLVE THE ISSUE. THE ISSUES WERE RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278980 SURESCAN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MPRI 978B128 VA2BSHZ 00763000203726

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR