BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3032282 · Received March 29, 2013

    Report

    Report Number
    1627487-2013-01351
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 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

    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 2 OF 2. REF MFR REPORT:1627487-2013-01350. IT WAS REPORTED THE PT WENT TO THE ER ON (B)(6) 2013 DUE TO FEVER, INCISIONAL DISCOMFORT AND REDNESS AT HER IPG AND LEAD SITES. THE PT WAS TREATED WITH ORAL ANTIBIOTICS. ON (B)(6) 2013, THE PT'S LEAD INCISION LOOKED BETTER, BUT THE IPG POCKET INCISION DID NOT. THE PT WAS ADMITTED TO THE HOSP ON (B)(6) 2013 AND WAS TREATED WITH IV ANTIBIOTICS. THE PT'S ENTIRE SCS SYSTEM WAS REMOVED AND BOTH SITES WERE CULTURED. THE PT'S IPG POCKET SITE CULTURE WAS POSITIVE FOR (B)(6). THE PT IS DOING BETTER AND IS STILL RECEIVING IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130080 PENTA SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3228 3787662

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R