BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 3900138 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15397
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 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 AN 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 EXPERIENCES PAIN AND DISCOMFORT AT THE EXTENSION SITE. THE PATIENT'S IPG WAS PREVIOUSLY EXPLANTED (REFERENCE MFR REPORT: 1627487-2013-21138). SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE EXTENSION WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315084 DUAL EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3343 3915506

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: