BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LEAD EXTENSION

    MDR report key: 2092564 · Received May 3, 2011

    Report

    Report Number
    1627487-2011-02524
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    November 25, 2010
    Report Date
    April 4, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORTS: 1627487-2011-02523. THE PT RECEIVED HER SCS SYSTEM WHICH INCLUDED TWO PERCUTANEOUS LEADS (OF THE SAME LOT) AND TWO EXTENSIONS (OF THE SAME LOT). IT WAS REPORTED THE PT BEGAN EXPERIENCING POSITIONAL OVERSTIMULATION AT THE IPG POCKET FOLLOWING A FALL ON (B)(6) 2010. ON (B)(6) 2011, THE PT PRESENTED TO THE EMERGENCY ROOM REPORTING EROSION OF THE LEAD. NO INFECTION WAS PRESENT. THE SCS SYSTEM WAS IMMEDIATELY EXPLANTED ON (B)(6) 2011 AND NOT REPLACED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LEAD EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3126632

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788