BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3950238 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-23417
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 29, 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'S SCS SYSTEM IS NOT RELIEVING HIS PAIN LIKE IT USED TO IN THE PAST. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING WAS ABLE TO PROVIDE STIMULATION TO HIS LEFT HIP WHICH WAS WHERE THE PATIENT'S INTENSE PAIN WAS, HOWEVER, THE PATIENT REPORTS THE PAIN IS MUCH DEEPER IN HIS HIP. FOLLOW UP INFORMATION REVEALED THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 WHEN HIS ENTIRE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360787 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3467810

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788