BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4132801 · Received September 29, 2014

    Report

    Report Number
    1627487-2014-01637
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    February 12, 2014
    Report Date
    September 9, 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

    THE PT ALLEGES STIMULATION IS INTERMITTENT AND SPORADIC WHEN THE AMPLITUDE'S INCREASED. FURTHER INFO REVEALS ONE OF THE LEAD CONTACTS HAD INVALID IMPEDANCE; HOWEVER, REPROGRAMMING RESOLVED THE ISSUE. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING AND REPLACING THE SCS SYSTEM. THE PHYSICIAN ELECTIVELY REPLACED THE IPG AND ANCHORS WITH NEWER MODELS. EFFECTIVE STIMULATION WAS ACHIEVED POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606955 PENTA GZB ST JUDE MEDICAL - NEUROMODULATION 3228 3413599

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS IPG: MODEL 3716,| IMPLANT DATE:| SCS ANCHOR: MODEL 1192,| SCS ANCHOR: MODEL 1194,| IMPLANT DATE:| IMPLANT DATE: