BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 8405503 · Received March 8, 2019

    Report

    Report Number
    3004209178-2019-04872
    Event Type
    Injury
    Date Received
    March 8, 2019
    Report Date
    March 11, 2019
    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
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# V062321, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER OF A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE/HERNIATED DISC PAIN. IT WAS REPORTED THAT THE PATIENT¿S DEVICE AND THERAPY HAVE NOT BEEN WORKING FOR A FEW YEARS AND THE PATIENT NEEDS TO HAVE THE INS REPLACED. IT WAS REPORTED THAT THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE AND WAS TOLD THAT SOME OF THE LEADS WERE WORKING AND SOME WERE NOT. IT WAS REPORTED THAT THE ¿POWER FROM THE INS¿ WAS GETTING TO SOME OF THE LEADS BUT NOT OTHERS. THE PATIENT IS WORKING WITH THEIR HEALTHCARE PROVIDER (HCP) TO HAVE THE INS REPLACED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT WAS SEEN BY A MANUFACTURER REPRESENTATIVE IN THEIR DOCTOR'S OFFICE ON (B)(6) 2019. IT WAS REPORTED THAT ALL ELECTRODES HAD IMPEDANCES OF OVER 10,000 OHMS, AND THE PATIENT FELT NO STIMULATION. IT WAS REPORTED THAT THE PATIENT HAD THE WHOLE SYSTEM REPLACED ON (B)(6) 2019. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196558 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention