BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3110676 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-01502
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2013-01501. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION AND COULD NOT COMMUNICATE WITH HIS IPG. HE OBSERVED COMMUNICATION ERRORS WITH HIS PROGRAMMER. A REPLACEMENT PROGRAMMER DID NOT RESOLVE THE ISSUE. THE PT'S IPG WAS REPLACED WITH A NEW ONE. X-RAYS TAKEN DURING THE PROCEDURE SHOWED THE LEAD HAD MIGRATED. THE PHYSICIAN NOTED THE LEAD WAS KINKED SO HE REPLACED THE LEAD WITH A NEW ONE. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207883 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3163 3190267

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192