BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3001476 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01253
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    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 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

    THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS INDICATED ONE OF THE LEFT SIDED QUATTRODE LEADS SHOWED 3/4 CONTACTS WERE INVALID. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT'S 2ND LEFT SIDED QUATTRODE LEAD IS FUNCTIONING PROPERLY AS WELL AS THE RIGHT SIDED OCTRODE LEAD. X-RAYS HAVE BEEN ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92976 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3627362

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS LEAD, MODEL 3186| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3716| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| SCS EXTENSION, MODEL 3341