BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2881105 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-13219
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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: 1627487-2012-13218. IT WAS REPORTED, THE PT'S LEAD MIGRATED. X-RAYS CONFIRMED THE ISSUE. F/U INFO IDENTIFIED THE PHYSICIAN OPTED TO REMOVE THE LEADS AND ANCHORS DURING A SURGICAL PROCEDURE. THE PHYSICIAN STATED, THE OCTRODE LEAD LOOKED CRIMPED. WHEN TESTED, ALL CONTACTS WERE INVALID. THE PHYSICIAN ALSO STATED HE WAS UNABLE TO PLACE A NEW OCTRODE LEAD DUE TO THE FORMATION OF SCAR TISSUE. HE ALSO TRIED TO ADVANCE THE QUATTRODE LEADS, BUT WAS UNABLE TO GET INTO THE EPIDURAL SPACE. THE PHYSICIAN OPTED TO ABORT THE PROCEDURE AND REFER THE PT FOR A PADDLE LEAD PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3146 3218951

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention EXPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (3)| IMPLANT DATE:| SCS EXTENSION: MODEL 3341