BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2770396 · Received October 1, 2012

    Report

    Report Number
    1627487-2012-06484
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    April 23, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    EVALUATION: RESULTS: AS RECEIVED, THE LEAD HAD A DAMAGED ELECTRODE WITH THE CORRESPONDING WIRE BROKEN ON THE PADDLE. THE DAMAGE IS CONSISTENT WITH THE EXPLANT PROCEDURE. NO PRE-EXPLANT DAMAGE WAS IDENTIFIED. FUNCTIONAL TESTING REVEALED THAT ALL BUT THE DAMAGED CONTACT PASSED CONDUCTIVITY AND STRESS TESTING. 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. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE, THE DOCTOR DAMAGED THE LEAD WHILE ATTEMPTING TO REPOSITION IT. THE LEAD WAS EXPLANTED AND REPLACED. COVERAGE WAS REGAINED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3601636

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXPLANT:| SCS IPG, MODEL: 3788| IMPLANT: