BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2092711 · Received May 10, 2011

    Report

    Report Number
    1627487-2011-02572
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    THE PT RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. TWO MONTHS POSTOPERATIVE, THE PT BEGAN EXPERIENCING PAIN IN HIS GENITALS. THE PAIN WAS PRESENT WITH OR WITHOUT STIMULATION. OVER TIME, THE PAIN BECAME TOO MUCH FOR THE PT TO MANAGE AND HE REQUESTED THE SCS SYSTEM BE EXPLANTED AND NOT REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT'S STATUS AND, IF AVAILABLE, DIAGNOSIS, WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3179692

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS IPG, MODEL: 3788| IMPLANT: