BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012292 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-04308
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 20, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-04309. IT WAS REPORTED THE PT HAD FELT A SHOCKING SENSATION. THE SJM REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING, AND ALL CONTACTS ON THE LEAD HAD NORMAL IMPEDANCES. IT WAS REPORTED SOME CONTACTS WERE UNABLE TO BE USED DURING REPROGRAMMING. FOLLOW UP IDENTIFIED THE PHYSICIAN REPOSITIONED BOTH LEADS ON (B)(6) 2013. IT WAS REPORTED THE SURGICAL INTERVENTION RESOLVED THE ISSUE, AND THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104716 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3861960

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED:| SCS ANCHOR: MODEL 1192 (2)| IMPLANTED: