BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3123545 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-10159
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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

    IT WAS REPORTED THE PT WAS SEEN FOR A ROUTINE VISIT APPROXIMATELY TWO MONTHS FOLLOWING SURGERY. AT THAT TIME, THE PHYSICIAN OBSERVED THAT THE WOUND ON THE PT'S BACK AT THE ENTRANCE OF THE SCS LEAD HAD OPENED (B)(6). AS A RESULT, THE PHYSICIAN ELECTED TO REMOVE THE LEAD AS A PREVENTATIVE MEASURE TO AVOID INFECTION. IT WAS NOTED THE IPG REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218604 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3847676

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention