BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 8784740 · Received July 12, 2019

    Report

    Report Number
    3004209178-2019-13382
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    March 10, 2019
    Report Date
    March 8, 2023
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: THE CODING HAS BEEN UPDATED. CONTINUATION OF D10: PRODUCT ID 3778-60 SERIAL# (B)(6) IMPLANTED: (B)(6) 2010 EXPLANTED: (B)(6) 2019 PRODUCT TYPE LEAD PRODUCT ID 3550-39 LOT# UNKNOWN PRODUCT TYPE ACCESSORY. 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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD AND ANCHOR FOUND NO ANOMALIES OF THE DEVICES. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD ,PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN. PRODUCT TYPE UNKNOWN, PRODUCT ID 3550-39, LOT# UNKNOWN. PRODUCT TYPE ACCESSORY. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. EVALUATION CONCLUSION CODE DOES NOT APPLY. EVALUATION METHOD DOES NOT APPLY. EVALUATION RESULT CODE DOES NOT APPLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE AND A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS MIGRATED TO L1 AND THE OTHER LEAD WAS INTACT AND FUNCTIONAL AT THE IMPLANT LOCATION. THE PATIENT FELL IN (B)(6) OF 2019 WHICH MIGHT HAVE CONTRIBUTED TO THE ISSUE. DURING EXPLANT THE HCP COMPLAINED THE ANCHOR FOR THE LEAD AND NOTED THAT THEY WOULD ALWAYS BREAK. PRIOR TO THE PATIENT'S REVISION IMPEDANCES WERE WITHIN THE NORMAL LIMIT FOR BOTH LEADS. ONE LEAD WAS SURGICALLY REMOVED AND THE OTHER REMAINED IMPLANTED. REPROGRAMMING WAS ATTEMPTED USING THE REMAINING LEAD IN THE ORIGINAL POSITION AND IT WAS SUFFICIENTLY COVERING ALL PAIN AREAS- THE HCP ELECTED TO NOT REPLACE THIS LEAD. THE ISSUE WAS NOTED AS BEING RESOLVED. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGARDING THE PATIENT. IT WAS REPORTED THAT THE CAUSE OF THE ANCHOR ALWAYS BREAKING REMAINS UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578955 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention "SEE H10...."