BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE PERCUTANEOUS LEAD

    MDR report key: 2092882 · Received May 11, 2011

    Report

    Report Number
    1627487-2011-01500
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    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 PATIENT RECEIVED HER SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT FELT DECREASED STIMULATION. REPROGRAMMING EFFORT WERE UNSUCCESSFUL, AND ONE OF THE LEADS EXHIBITED INVALID AND HIGH IMPEDANCE MEASUREMENTS ON MULTIPLE LEAD CONTACTS. X-RAY FOUND NO ANOMALIES. THE PATIENT DENIED ANY FALLS OR EXTREME/SUDDEN BODY MOVEMENTS. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD WITH A PADDLE LEAD ON (B)(6) 2011. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3146 3218951

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS LEAD, MODEL 3186, IMPLANT:| SCS LEAD ANCHOR, MODEL 1192, IMPLANT:| SCS LEAD EXTENSION, MODEL 3341, IMPLANT:| SCS IPG, MODEL 3788, IMPLANT: