BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY MRI IPG

    MDR report key: 6817737 · Received August 24, 2017

    Report

    Report Number
    1627487-2017-04573
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 14, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT'S ((B)(6)) IPG WAS INOPERABLE AS THE PATIENT HAD NOT CHARGED THE IPG IN SEVERAL WEEKS. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT THE IPG. EXPLANT DATE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2017 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE. IN ADDITION, THE PATIENT DISCONTINUED CHARGING THE IPG DUE TO BEING IN THE INTENSIVE CARE UNIT.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED THE REASON FOR THE PATIENT BEING IN INTENSIVE CARE UNIT (WHICH RESULTED IN LACK OF CHARGING) WAS UNRELATED TO THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596760 PRODIGY MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3772 5416718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other