BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 60-CM LENGTH PADDLE LEAD

    MDR report key: 2181333 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-03308
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 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 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-03328. THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT HAS A (B)(6) INFECTION AT HER LEAD INCISION SITE. PATIENT IS RECEIVING ANTIBIOTIC THERAPY. FOLLOW-UP FOUND THE INFECTION WAS GETTING BETTER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 60-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3269068

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention