BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4001559 · Received June 30, 2014

    Report

    Report Number
    1627487-2014-01429
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WITH LEAD PLACEMENT DUE TO THE PT'S ANATOMY AND CALCIFIED TISSUE. REPORTEDLY, A LAMINOTOMY WAS PERFORMED SUBSEQUENTLY ADVANCING THE LEAD TO THE DESIRED LOCATION. AS A RESULT, THE PROCEDURE WAS EXTENDED APPROXIMATELY 1.5 HR. THE PROCEDURE WENT WITHOUT FURTHER INCIDENT OR CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381377 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4407199

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other SCS IPG: MODEL 3789| IMPLANT DATE: