BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12520250 · Received September 23, 2021

    Report

    Report Number
    3004209178-2021-14319
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    December 11, 2019
    Report Date
    December 20, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3093-28 LOT# V926162 SERIAL# IMPLANTED: (B)(6) 2012. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THERE WAS NO PATIENT HARM OR SYMPTOMS RELATED TO THE LEAD BEING LEFT INSIDE THE PATIENTS BODY. NO ADDITIONAL SURGERY WAS PLANNED TO REMOVE THE COMPONENT AND THE NORMAL EXPLANT PROCEDURE WAS FOLLOWED. THE DAMAGE OCCURRED DURING EXPLANT. THE CAUSE OF THE LEAD FRAGMENT REMINING IN THE PATIENT/LEAD DAMAGE WAS DETERMINED TO BE THE POSITIONING OF THE LEAD. PATIENT WAS INFORMED AND ALSO IT IS CLEARLY STATED IN THE OR REPORT OF 2019. THE HCP REPORTED THAT 90% OF THE CASES LEADS CAN BE REMOVED IN ITS ENTIRETY. IF LEADS LIKE THIS ONE EXTEND UNDERNEATH THE SACRUM THEY OFTEN BREAK DESPITE THE BEST EFFORT OF THE SURGEON. THE LEAD WAS NOT INSERTED BY THE EXPLANTING SURGEON. NO ISSUES HAVE BEEN REPORTED FROM SMALL LEAD FRAGMENTS LEFT IN PLACE IF REMOVED FOR REASONS AS A NON DESIRED DEVICE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V926162 , IMPLANTED:(B)(6) 2012 ,EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019. THE DR THOUGHT THEY GOT EVERYTHING OUT BUT AN X-RAY SHOWED A TINY PART OF THE LEAD WAS LEFT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416443 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female "SEE H10...."