BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS- IPG

    MDR report key: 6952660 · Received October 16, 2017

    Report

    Report Number
    1627487-2017-06164
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-060217-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INOPERABLE WHEN EXPOSED TO MONOPOLAR ELECTROSURGERY ADVISORY NOTICE ISSUED BY ABBOTT ON 02 JUNE 2017. THE MANUFACTURER 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 THAT THE PATIENT'S ((B)(6)) IPG IS NO LONGER ABLE TO COMMUNICATE WITH THE PATIENT CONTROLLER. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    FOLLOW UP REVEALED THAT THE PATIENT (B)(6) UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 TO HAVE THEIR IPG REPLACED. ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730823 SCS- IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3665 6000231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other