BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY ENHANCED

    MDR report key: 11624651 · Received April 6, 2021

    Report

    Report Number
    2182207-2021-00588
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 8, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN PRODUCT TYPE LEAD 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 · 0

    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.

    Description of Event or Problem · 0

    THE HCP REPORTED THAT THE INFECTION HAD BEEN RESOLVED. THEY ALSO REPORTED INFORMATION REGARDING THE TRIAL PROCEDURE PERFORMED ON (B)(6)2021 AT ABOUT 1:30PM. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM AND PLACED IN THE PRONE POSITION. PRESSURE POINT AREAS WERE ADEQUATELY PADDED. THEY WERE PREPPED AND DRAPED IN THE USUAL STERILE MANNER, AND INTRAVENOUS ANTIBIOTICS WERE GIVEN PER SURGICAL CARE IMPROVEMENT PROJECT (SCIP) PROTOCOL. MONITORED ANESTHESIA CARE (MAC)/LOCAL ANESTHESIA WAS ADMINISTERED. TIME OUT WAS PERFORMED AND ALL AGREED. FLUOROSCOPY WAS USED TO IDENTIFY THE CORRECT LANDMARKS FOR NEEDLE PLACEMENT. S3 WAS ENTERED ON THE RIGHT SIDE ONLY, AND THE BEST NERVE RESPONSE WAS OBTAINED ON LEAD 3. THE TINED LEAD WAS PLACED INTO S3 IN THE APPROPRIATE LOCATION WITH THE USE OF FLUOROSCOPY. THE #3 ELECTRODE HAD THE BEST THRESHOLD STIMULATION LEVEL. A POCKET WAS MADE ON THE RIGHT SUPERIOR GLUTEAL AREA, AND THE LEAD TUNNELED INTO IT. IT WAS THEN ATTACHED TO THE TEMPORARY EXTERNAL WIRES. THE EXTERNAL WIRES WERE THEN TUNNELED TO THE CONTRALATERAL SIDE AND THE LEAD POCKET WAS CLOSED WITH INTERRUPTED 3-0 SUBCUTICULAR SYNTHETIC SUTURE. ALL SKIN INCISIONS WERE CLOSED WITH A TOPICAL SKIN ADHESIVE. THE MANUFACTURER REPRESENTATIVE THEN SECURED THE EXTERNAL STIMULATING WIRES PER PROTOCOL. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU) IN STABLE CONDITION. THERE WERE NO COMPLICATIONS AND NO SPECIMENS WERE REMOVED OR ALTERED. THE ESTIMATED BLOOD LOSS WAS 2 ML, AND THE FINDING WAS THE RIGHT LEAD WAS IN THE S3 SACRAL FORAMINA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. THEY REPORTED THE INDICATION FOR USE WAS URINARY INCONTINENCE AND URGE FREQUENCY. THE NOTED THE MODEL/LOT INFORMATION FOR THE LEAD WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT  THE PATIENT HAD AND INFECTION OCCURRED DURING THEIR STAGE 1 TRIAL AND THE LEAD HAD TO BE REMOVED AND PATIENT TREATED WITH ANTIBIOTICS. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516541 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention