BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2973611 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-15225
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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. REF MFR REPORT: 1627487-2013-15226. IT WAS REPORTED, THE PT HAD A PAINFUL LUMP THAT WAS SWOLLEN, RED AND OOZING FLUID AT THE SURGICAL LEAD IMPLANT SITE. THE PHYSICIAN CLEANED THE AREA AND REFERRED THE PT TO A PLASTIC SURGEON. IT IS UNK, IF THE PT CONSULTED WITH A PLASTIC SURGEON. APPROX TWO WEEKS LATER, THE PT SAW HIS PHYSICIAN AGAIN AND INDICATED PAIN, REDNESS AND WARMTH AT HIS IPG SITE. THE PHYSICIAN SENT THE PT TO THE EMERGENCY ROOM FOR FURTHER EVAL. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72419 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 3346022

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention