BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2003734 · Received February 23, 2011

    Report

    Report Number
    1627487-2011-00250
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 # 1627487-2011-00249. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT HIS SYSTEM WAS EXPLANTED ON (B)(6) 2011 DUE TO AN INFECTION FOUND AT THE LEAD INCISION SITE. CULTURE RESULTS INDICATED A (B)(6) FOR WHICH ANTIBIOTICS WERE ADMINISTERED. A CONSULTATION WITH AN INFECTIOUS DISEASE SPECIALIST WAS ALSO SCHEDULED. NO FURTHER INFO IS AVAILABLE.

    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 DIV. 3228 3123985

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention