BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3052348 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-06142
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALY 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 INFO 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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-06143. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. AN SJM REP MET WITH THE PT AND ATTEMPTED TO REPROGRAM THE PT'S SYSTEM BUT WAS NOT ABLE TO OBTAIN SATISFACTORY STIMULATION. X-RAYS WERE TAKEN AND CONFIRMED THE LEAD HAD MIGRATED. SURGERY WAS PLANNED TO REVISE THE LEAD. F/U INDICATED THAT, DURING THE LEAD REVISION SURGERY, IT WAS DISCOVERED THE PT HAD AN INFECTION AT THE LEAD AND THE IPG SITES. THE SCS SYSTEM WAS EXPLANTED AND THE PT WAS TREATED WITH IV ANTIBIOTICS, THE IMPLANT SITES WERE ALSO FLUSHED WITH THE ANTIBIOTIC. THE TYPE AND CAUSE OF THE INFECTION IS UNK. F/U INDICATES A CULTURE SHOWED THE PT WAS GRAM POSITIVE FOR AN INFECTION. THE IPG SITE INCISION WAS HEALED, BUT THE PT IS STILL HOSPITALIZED FOR THE LEAD INCISION, AND CURRENTLY HAS A WOUND VACUUM-ASSISTED CLOSURE OVER THE SITE, AND IS BEING TREATED WITH IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139177 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3860321

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R EXPLANT DATE:| SCS ANCHOR: MODEL 1194| EXPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192