BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4201972 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-26858
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    DEVICE 1 OF 2: REF MFR REPORT: 1627487-2014-26859. THE PT'S SPOUSE REPORTS THE PT IS EXPERIENCING AUTO-REDUCING ON ALL OF HER PROGRAMS. THE SJM REP MET WITH THE PT AND INITIALLY REPROGRAMMING WAS ABLE TO RESOLVE THE ISSUE. FOLLOW UP INFO IDENTIFIED THE ISSUE HAS RECURRED AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. LEAD DIAGNOSTICS REVEALED HIGH IMPEDANCE. SURGICAL INTERVENTION MAY BE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663450 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3869132

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788,| IMPLANT DATE:| SCS EXTENSION, MODEL 3383,