BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3890645 · Received June 3, 2014

    Report

    Report Number
    1627487-2014-08012
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    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
    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 HAD EXPERIENCED LEAD MIGRATION. PATIENT HAD GOOD COVERAGE PRIOR TO REVISION BUT WAS HAVING POSITIONAL STIMULATION DUE TO LEAD MOVING DOWN AND GOING INTO THE GUTTER. PATIENT HAD REVISION SURGERY ON (B)(6) 2014 TO REPOSITION HER LEAD. PROGRAMMING WAS SUCCESSFUL POST-OPERATIVELY, THEREBY RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324872 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4420094

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other SCS IPG: MODEL 3788| IMPLANT: