BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 8687079 · Received June 11, 2019

    Report

    Report Number
    3004209178-2019-11316
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    February 5, 2018
    Report Date
    March 30, 2020
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 377845 LOT# V013770 SERIAL# IMPLANTED: (B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 377845 LOT# V013770 SERIAL# IMPLANTED: (B)(6) EXPLANTED: 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) IN A CLINICAL STUDY (SDY). IT WAS REPORTED THAT THE STIMULATION WAS STINGING THE PATIENT IN THE BACK WHEN IT WAS ON AS OF (B)(6). THE THERAPY WAS SUSPENDED ON (B)(6) AND THE EVENT WAS UNRESOLVED WITH NO FURTHER ACTIONS PLANNED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377845, LOT# V013770, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 377845, LOT# V013770, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377845, LOT# V013770, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 377845, LOT# V013770, IMPLANTED: (B)(6) 2006, PRODUCT TYPE; LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377845, SERIAL/LOT #: (B)(4), UBD: 18-OCT-2010, UDI#: (B)(4); PRODUCT ID: 377845, SERIAL/LOT #: (B)(4), UBD: 18-OCT-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT PRODUCTS: PRODUCT ID 377845, LOT# V013770 , IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377845, LOT# V013770, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) IN A CLINICAL STUDY (SDY). IT WAS REPORTED THAT THE EVENT WAS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2019.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT IN A CLINICAL STUDY (SDY) WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR EPIDURAL FIBROSIS. IT WAS REPORTED THAT THE PATIENT WAS GETTING A SHOCKING SENSATION FROM THE LEADS, EVEN AFTER THE DEVICE HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE STIMULATOR WAS NOT BEING USED AND NO ACTIONS WERE TAKEN AT THIS POINT. THE EVENT WAS NOTED TO BE ONGOING. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    NO NEW INFORMATION WAS REPORTED (THE PATIENT'S WEIGHT AND THE DATE OF THE EVENT WERE REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481568 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR