BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3295493 · Received August 19, 2013

    Report

    Report Number
    3004209178-2013-14792
    Event Type
    Injury
    Date Received
    August 19, 2013
    Report Date
    July 23, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37083-40 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37083-40 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3998 LOT# V110881, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ONLY HAD ONE DEVICE, THE LAST ONE WAS REPLACED DUE TO SOME WIRE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401284 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1