BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 8219620 · Received January 4, 2019

    Report

    Report Number
    3004209178-2019-00311
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    January 1, 2008
    Report Date
    January 4, 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
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377860, LOT# V010409, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THE PATIENT HAD BEEN THROUGH 3-4 PROCEDURES WITH HIS DEVICE AND HAD THE INS AND LEADS REPLACED. THE PATIENT REPORTED THE FIRST INS WAS IMPLANTED IN 2006 OR 2007. HE HAD TROUBLE WITH IT BUT COULD NOT REMEMBER WHAT HAD HAPPENED. IT HAD NOT BEEN MORE THAN 2 YEARS. THEY DECIDED THAT EITHER THE LEADS BROKE OR SOMETHING HAPPENED TO THE UNIT. AT THAT TIME THERE WAS AN UPGRADE IN THE UNITS, SO THEY WENT AHEAD AND PUT THE DEVICE IN WITH AN UPGRADE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11873 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention