BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3141940 · Received May 28, 2013

    Report

    Report Number
    1627487-2013-05738
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    October 5, 2012
    Report Date
    May 1, 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

    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 3. REFERENCE MFR. REPORT #: 1627487-2013-05737, # 1627487-2013-05739. IT WAS REPORTED THE PATIENT DID NOT TRUST HIS SCS SYSTEM ANYMORE AFTER RECEIVING THE IPG RECALL LETTER. THE PATIENT ALSO DECLINED REPROGRAMMING DUE TO RECEIVING THE IPG RECALL LETTER. AS A RESULT, THE PATIENT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WAS DISPOSED OF BY THE SURGICAL FACILITY. SJM WAS UNAWARE OF THE EXPLANT UNTIL (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233416 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3530261

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention SCS ANCHOR: MODEL: 1192| IMPLANT:| EXPLANT: