BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3872803 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11587
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 22, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DO NOT HAVE CONCERNS WITH THEIR DEVICE AND RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE ON 2014-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS ONLY LASTED 1.5-2 YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350186 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention