BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 4760950 · Received May 8, 2015

    Report

    Report Number
    1627487-2015-05239
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2015 DUE TO RECEIVING INADEQUATE COVERAGE. DURING THE PROCEDURE, THE DOCTOR RELOCATED THE PATIENT'S LEAD. SURGICAL INTERVENTION RESOLVED THE PATIENT'S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304904 PENTA 3MM LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4464207

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other MODEL: 3788, SCS IPG