BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3900098 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15406
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO MEET SPECIFICATIONS. NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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 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 2 OF 2. REFERENCE MFR REPORT : 1627487-2014-15405. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IPG AND SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THAT PATIENT'S PHYSICIAN INDICATED THE INCISIONS ARE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315145 PENTA SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3228 4286994

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other