BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3060204 · Received April 5, 2013

    Report

    Report Number
    1627487-2013-05468
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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

    ON (B)(6) 2013, THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. DURING THE PROCEDURE, THE DOCTOR ANALYZED THE LEAD AND THOUGHT IT WAS DEFECTIVE. AS A RESULT, ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139812 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3895349

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention