BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3803053 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08820
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 24, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-75, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LEADS MOVED. THE PATIENT COULD NOT PROVIDE MORE DETAILS AND DATES REGARDING THE LEAD. THE PATIENT STATED THAT THEY ¿MUST HAVE TAKEN A FALL AT ONE POINT.¿ IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) REPLACED THE STIMULATOR AND IMPLANTED A DIFFERENT ONE. SEE MANUFACTURER REPORT #3004209178-2014-08811 FOR AN EVENT CONTAINING THE SAME IMPLANTED DEVICES. THE EVENT PERTAINED TO AN ALLEGATION THAT PAIN RELIEF STOPPED. IT WAS UNCLEAR IF THE ALLEGATION OF THE LEAD MIGRATION WAS RELATED OR UNRELATED TO THE ALLEGATION PAIN RELIEF STOPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282020 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention