BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4112936 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-08289
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT WAS UNABLE TO INCREASE HIS SCS SYSTEM STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PT FOR SYSTEM INTERROGATION AND DETERMINED THE PT'S SCS LEADS HAD INVALID IMPEDANCES. X-RAYS TAKEN SHOW THE PT'S LEAD HAD FRACTURED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577064 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3582909

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other SCS IPG: MODEL 3788| IMPLANTED: