BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3032046 · Received March 26, 2013

    Report

    Report Number
    1627487-2013-06097
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2012
    Report Date
    March 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-06096. THE PT WAS IMPLANTED WITH TWO WIDE SPACED LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT DURING A SCHEDULED APPOINTMENT WITH HIS PHYSICIAN TO REPLACE THE PT'S IPG DUE TO RECHARGE BURDEN, THE PT REPORTED THAT ONE OF THE LEADS WAS CAUSING HIM UNCOMFORTABLE STIMULATION. THE PHYSICIAN DECIDED TO REVISE THE LEAD DURING THE IPG REPLACEMENT PROCEDURE. BUT, DURING THE PROCESS THE PHYSICIAN ACCIDENTALLY CUT THE LEAD AND THE LEAD WAS EXPLANTED AND REPLACED. FOLLOW-UP INDICATES A SJM REP MET WITH THE PT AFTER THE SURGERY AND REPORTS THE PT HAS GOOD COVERAGE OF ALL HIS PAIN AREAS AND HE IS PLEASED WITH THE STIMULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124188 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 3150054

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS LEAD, MODEL 3186 (X2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: