BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3891839 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-05427
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 22, 2013
    Report Date
    May 20, 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

    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#: 1627487-2014-05426. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION FOLLOWING BEING IMPLANTED ON (B)(6) 2014, THE TREATMENT FOR THE INFECTION IS UNKNOWN. ON (B)(6) 2014, THE PATIENT UNDERWENT A PROCEDURE TO HAVE AN ADDITIONAL SCS SYSTEM IMPLANTED FOR A NEW PAIN PATTERN. DURING THE PROCEDURE, PUS AND AN INFECTION WERE FOUND AT THE IPG SITE OF THE FIRST SCS SYSTEM. AS A RESULT, THE DOCTOR CLEANED THE POCKET SITE AND SOAKED THE IPG IN BETADINE. NEXT, THE DOCTOR PLACED THE IPG BACK IN IT'S ORIGINAL LOCATION. THE PATIENT WILL FOLLOW-UP WITH HIS DOCTOR AND WILL BE GIVEN ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339268 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3847820

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other