BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3123526 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-13759
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    December 13, 2012
    Report Date
    April 23, 2013
    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

    DEVICE 2 OF 3. REF MFR REPORT: 1627487-2013-13759 AND 1627487-2013-13760. IT WAS REPORTED THE PT BEGAN TO EXPERIENCE PAIN AT THE IPG POCKET SITE TWO DAYS POSTOPERATIVE. THE PT REPORTED SHE HAD AN INJECTION WITH A NUMBING MEDICATION TWO DAY POSTOPERATIVE AND ANOTHER INJECTION ON (B)(6) 2013. THE PT STATED THE PT BEGINS BELOW HER IPG INCISION AND RADIATES DOWN APPROXIMATELY SIX INCHES. THE PA STATED THE PT DOES NOT HAVE AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219081 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3820134

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)