BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3890467 · Received June 4, 2014

    Report

    Report Number
    1627487-2014-01388
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    IT WAS REPORTED THE IPG IS LOOSE IN THE POCKET AND AS A RESULT, THE PT'S EXPERIENCING PAIN AND TENDERNESS AT THE IPG SITE. REPORTEDLY, CHARGING HAS BEEN DIFFICULT FOR THE PAST SEVERAL MONTHS AS WELL AS THE ABILITY TO MAINTAIN A CONNECTION. THE PT EXPERIENCED A WEIGHT DECREASE AND SUBSEQUENTLY A PREVIOUS INCREASE. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON 06/03/2014. THE ORIGINAL IPG WAS EXPLANTED AND REPLACED WITH A SMALLER DEVICE. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327336 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 86057

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)