BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS CONVENTIONAL IPG

    MDR report key: 2051541 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01350
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01351. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2008. IT WAS REPORTED THAT THE PT LOST STIMULATION, AND THE PT'S IPG WAS UNABLE TO COMMUNICATE WITH THE PROGRAMMER. A REPLACEMENT PROGRAMMER WAS UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PAIN PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE PT'S IPG. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE LEAD WAS FRACTURED AND TANGLED IN A KNOT. THE LEAD WAS ALLEGEDLY CUT AT THE TAIL FOR REMOVAL, AND THE PADDLE PORTION WAS LEFT IMPLANTED. FOLLOW UP ON THE PT FOUND THAT THE PT'S EXISTING PORTION OF THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2011 BY A SURGEON. THE EXPLANTED PADDLE PORTION OF THE LEAD WAS DISCARDED BY THE FACILITY. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3608 R117973

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention