BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCS IPG

    MDR report key: 6214553 · Received December 29, 2016

    Report

    Report Number
    1627487-2016-06635
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    November 15, 2016
    Report Date
    June 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
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    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.

    Description of Event or Problem · 1

    PATIENT HAD SURGICAL INTERVENTION TO REPLACE THE IPG ON (B)(6) 2017. EFFECTIVE THERAPY WAS CONFIRMED AFTER SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S OCCIPITAL (OFF-LABEL) IPG IS INOPERABLE, WHICH WAS CONFIRMED WITH THE CLINICIAN PROGRAMMER. THE PATIENT IS PLANNED TO UNDERGO SURGICAL INTERVENTION TO REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863628 SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 5491488

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other 3189, SCS LEADS (X2)