BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 7469139 · Received April 27, 2018

    Report

    Report Number
    2182208-2018-00791
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    December 28, 2017
    Report Date
    May 21, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. IMPLANTABLE PULSE GENERATOR (IPG) MODELS INCLUDE: 8968; 8160; 303; DR401; 7960; 900. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:SAFETY OF MAGNETIC RESONANCE IMAGING IN PATIENTS WITH CARDIAC DEVICES. NEW ENGLAND JOURNAL OF MEDICINE. 2017; 377(26):2555-2564. DOI: 10.1056/NEJMOA1604267 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THE PHYSICIAN AUTHOR REPORTED THERE WERE NO SIGNIFICANT ADVERSE EVENTS AS PART OF THE STUDY. NO ADDITIONAL INFORMATION WAS RECEIVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPG) AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT PATIENTS UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) SCANS WHILE IMPLANTED WITH LEGACY DEVICES/ NOT MRI CONDITIONAL. IT WAS NOTED THAT THE PACING MODE WAS CHANGED TO ASYNCHRONOUS MODE FOR PACING-DEPENDENT PATIENTS AND TO DEMAND MODE FOR OTHER PATIENTS. AFTER THE MRI SCAN, DEVICES EXHIBITED POWER ON RESET (POR). ONE PATIENT WITH AN ICD EXPERIENCED A PULLING SENSATION IN THEIR CHEST DURING THE SCAN. DEVICES FUNCTION WAS FULLY RESTORED AFTERWARDS TO ALL DEVICES. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311714 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention