BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE - DBS

    MDR report key: 3142291 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-10169
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. 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

    THE PT ((B)(6)) HAS A DBS SYSTEM WHICH INCLUDES 2 LEADS FROM THE SAME LOT. IT WAS REPORTED HIGH IMPEDANCE VALUES WERE IDENTIFIED ON ONE OF THE LEADS. X-RAY IMAGERY RULED OUT DISCONNECTION BETWEEN THE LEAD AND THE LEAD EXTENSION AS WELL AS THE LEAD EXTENSION AND THE IPG. INTRA-OPERATIVE TESTING WITH AN EXTERNAL STIMULATOR WILL BE CONDUCTED AT A LATER DATE TO ADDRESS THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234087 QUATTRODE - DBS DBS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 6143 176471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IMPLANT DATE:| DBS LEAD EXTENSION: MODEL 6345 (X2)| DBS IPG: MODEL 6788| IMPLANT DATE: