BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 8223530 · Received January 7, 2019

    Report

    Report Number
    2182208-2019-00040
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    January 1, 2018
    Report Date
    January 7, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. REFERENCED ARTICLE: INCIDENCE AND PREDICTORS OF MRI SCAN UTILIZATION IN MRI-CONDITIONAL PACEMAKER RECIPIENTS: A MULTICENTER EXPERIENCE. PACING AND CLINICAL ELECTROPHYSIOLOGY. 2018; 41(11):1519-1525. 10.1111/PACE.13503. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING MAGNETIC RESONANCE IMAGING CONDITIONAL PACEMAKERS. THE AUTHORS NOTED THE PERCENTAGE OF IMPLANT RELATED COMPLICATIONS AND THAT DURING THE FOLLOW UP PERIOD THERE WERE DEVICE RELATED MALFUNCTIONS. ADDITIONALLY, THERE WERE ALSO DEVICE RELATED INFECTIONS. THE STATUS OF THE DEVICES IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16594 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R