BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 8139190 · Received December 6, 2018

    Report

    Report Number
    3007566237-2018-03534
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    December 4, 2018
    Report Date
    February 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97791, LOT# UNKNOWN, PRODUCT TYPE ACCESSORY, PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS 3007566237. ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS 3004209178. DEVICE ANALYSIS FOR LEAD VA1HRTF008 REVEALED THE BODY CONDUCTOR BROKEN WITHIN 10 CM OF CONNECTOR AREA. ONE CONDUCTOR WAS BROKEN 2.7CM FROM THE PROXIMAL END. OTHER 3 CONDUCTORS WERE BROKEN 16.1 CM FROM THE PROXIMAL END. H6: CONCLUSION CODE BELONGS TO THE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS 3007566237. ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS 3004209178. 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 16-JUN-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTHCARE PROVIDER REPORTED VIA MANUFACTURE REPRESENTATIVE THAT THE PATIENT WAS EXPERIENCING CHANGES IN STIMULATION AND A DECREASE IN PAIN RELIEF. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE NOTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT¿S DEVICE WAS REPROGRAMMED, REPEATED IMPEDANCE TESTING AND EVENTUALLY THE LEAD WAS REPLACED. IT WAS NOTED THAT THE EVENT WAS RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978907 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention