BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 4844987 · Received June 15, 2015

    Report

    Report Number
    1627487-2015-12305
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 22, 2015
    Report Date
    September 20, 2019
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI(DI): (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REPORTED TO THE HOSPITAL EMERGENCY ROOM FOUR DAYS AFTER THE SCS IMPLANT PROCEDURE DUE TO LEG NUMBNESS AND INABILITY TO URINATE. THE PHYSICIAN PLACED A URINARY CATHETER AND THE PATIENT WAS TAKEN TO SURGERY IN ORDER TO EVACUATE AN EPIDURAL HEMATOMA. THE PATIENT'S SCS LEAD WAS EXPLANTED. COMPLICATIONS AROSE DURING THE PROCEDURE WHICH INCLUDED A PUNCTURED LUNG AND THE RUPTURE OF A MAJOR ARTERY. POSTOPERATIVELY THE PATIENT WAS PLACED ON DIALYSIS AND HAS VISUAL DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389628 PENTA 3MM LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 5009651

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening MODEL 3789, SCS IPG