BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3123544 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-05692
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 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

    IT WAS REPORTED, THE PT IS UNABLE TO RECEIVE ADEQUATE COVERAGE. AN IMPEDANCE CHECK REVEALED A LOW CONTACT. THE PT EXPERIENCED OVERSTIMULATION WHEN THE LOW CONTACT WAS USED. X-RAYS REVEALED LEAD MIGRATION. AS A RESULT, THE PT WILL UNDERGO A TRIAL PROCEDURE TO ADDRESS THE ISSUE, AND BECAUSE THE DOCTOR FEELS IT WOULD BE MORE SAFE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218901 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3763120

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: