BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2080430 · Received April 22, 2011

    Report

    Report Number
    1627487-2011-00540
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2011-00539. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2011 INCLUDING AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT THE PT EXPERIENCES SWELLING IN CERTAIN AREAS WHENEVER HER STIMULATION IS IN USE. THE PT WAS REFERRED TO HER PRIMARY CARE PHYSICIAN FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3228 3290635

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention