BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141778 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-08148
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COMPLAINT WAS NOT CONFIRMED. AS RECEIVED, THE LEAD SHOWED MISSING TIP ELECTRODE OF THE IPG'S END. FURTHER ANALYSIS SHOWED IT WAS LODGED INSIDE THE IPG LOWER CONNECTOR BLOCK, IT WAS CONSISTENT WITH LEAD PULLED FORCIBLY PRIOR TO RELEASING THE SETSCREW. 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

    DEVICE 2 OF 2. REF MFR REPORT #1627487-2013-18147. IT WAS REPORTED THE PT HAD HER PNS SYSTEM (OFF-LABEL USE) EXPLANTED ON (B)(6) 2013. PT WAS INITIALLY EXPERIENCING PAIN RELIEF BUT WAS HAVING NAUSEA FROM HER MEDICATION. LATER ON, IT WAS STATED THE PT WAS EXPERIENCING NUMBNESS IN HER HEAD AND WAS NOT HAVING PAIN RELIEF. PT WAS OFFERED THE REPROGRAMMING OPTION, BUT WAS DENIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232890 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3189 3741870

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS EXTENSION, MODEL 3386| IMPLANT DATE: