BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 6919340 · Received October 5, 2017

    Report

    Report Number
    3004209178-2017-20760
    Event Type
    Injury
    Date Received
    October 5, 2017
    Report Date
    October 5, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER REVIEW, EVENT OR PROBLEM WAS REVISED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. PRODUCT ID 377775, LOT# V013204, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. PRODUCT ID 747240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR POST LUMBAR LAMINECTOMY SYNDROME. A CONFIRMED ALLERGY WAS REPORTED. TOTAL SYSTEM EXPLANT WAS DONE TO RESOLVE THE ISSUE. ENCEPHALOPATHY WAS REPORTED AS A SYMPTOM. THE PATIENT¿S NEUROSTIMULATOR SYSTEM WAS EXPLANTED YEARS PRIOR TO (B)(6) 2017, AND IT WAS NOTED THAT IT HAD WORKED GREAT FOR HIS PAIN. THE PATIENT STILL HAD PAIN AND INQUIRED ABOUT ANOTHER SYSTEM. IT WAS NOTED THAT THE PATIENT HAD A NICKEL ALLERGY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR POST LUMBAR LAMINECTOMY SYNDROME. A CONFIRMED ALLERGY WAS REPORTED. TOTAL SYSTEM EXPLANT WAS DONE TO RESOLVE THE ISSUE. ENCEPHALOPATHY WAS REPORTED AS A SYMPTOM. THE PATIENT¿S NEUROSTIMULATOR SYSTEM WAS EXPLANTED YEARS PRIOR TO (B)(6) 2017, AND IT WAS NOTED THAT IT HAD WORKED GREAT FOR HIS PAIN. THE PATIENT STILL HAD PAIN AND INQUIRED ABOUT ANOTHER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695390 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