BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3821058 · Received May 7, 2014

    Report

    Report Number
    1627487-2014-25361
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR REPORT NUMBERS: 1627487-2014-25359 AND 1627487-2014-25360. IT WAS REPORTED BY THE SURGERY SCHEDULER, THE PT WAS UNDERGOING A SPINAL FUSION AND THE PHYSICIAN WANTED THE IPG EXPLANTED TO PERFORM THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS NO LONGER WORKING. IN TURN, THE PATIENT'S IPG WAS EXPLANTED. IT WAS NOT CONFIRMED IF THE SYSTEM WAS FUNCTIONAL. FOLLOW-UP REVEALED THE PATIENT'S IPG WAS EXPLANTED DUE TO THE PATIENT "DIDN'T FEEL IT WAS HELPING ANYMORE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276823 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL NEUROMODULATION 3146 28582

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other