BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3032372 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-10105
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 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
    SW
    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 REPORT: 1627487-2013-10104. IT WAS REPORTED HIGH IMPEDANCE VALUES WERE IDENTIFIED ON THE PT'S SCS LEAD EXTENSION ((B)(6)). THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION TO RESOLVE THE ISSUE. DURING THE PROCEDURE, THE PHYSICIAN REPORTEDLY PULLED TOO HARD ON THE LEAD EXTENSION CAUSING IT TO BREAK OFF INSIDE THE IPG HEADER. BOTH THE LEAD EXTENSION AND IPG WERE EXPLANTED AND REPLACED. IT WAS NOTED THE PROCEDURE WAS EXTENDED BY 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130126 GENESIS SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3224311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention