BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2892372 · Received December 27, 2012

    Report

    Report Number
    1627487-2012-16019
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    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 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

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING ADEQUATE COVERAGE. DURING SURGICAL INTERVENTION, THE DOCTOR DAMAGED THE PATIENT'S LEAD. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. THE REPLACEMENT LEAD RESOLVED THE PATIENT'S ISSUE. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3698140

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: