BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3161469 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-02782
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    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

    THE PATIENT HAS 2 SCS SYSTEMS (CERVICAL AND THORACIC) WHICH INCLUDE TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT'S CERVICAL SYSTEM ONLY PRODUCES STIMULATION ON THE LEFT SIDE. IT WAS REPORTED THE PHYSICIAN PLANNED TO REVISE THE LEAD. PER THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE CERVICAL LEAD WAS EXPLANTED AND REPLACED WITH TWO DIFFERENT MODEL LEADS ON (B)(6) 2013. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249005 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 4000139

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3788 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3228