BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2042078 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-00452
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 # 1627487-2011-00451. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT LOST STIMULATION. AN X-RAY WAS TAKEN WHICH REVEALED THAT THE LEAD HAD PULLED SLIGHTLY OUT OF THE HEADER OF THE IPG. SURGICAL INTERVENTION WAS UNDERTAKEN TO CORRECT THIS MATTER. AT THAT TIME, THE PHYSICIAN ELECTED TO REPOSITION THE LEAD IN AN EFFORT TO CAPTURE OPTIMAL THERAPY COVERAGE FOR THE PT. HOWEVER, THE LEAD WAS DAMAGED IN THE PROCESS. ADDITIONALLY, THE SET SCREW ALLEGEDLY DISENGAGED FROM THE IPG HEADER WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE NEW LEAD IN THE HEADER. BOTH THE LEAD AND IPG WERE REPLACED AS A RESULT OF THESE OCCURRENCES. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3260895

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention