BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7188712 · Received January 14, 2018

    Report

    Report Number
    2182208-2018-00010
    Event Type
    Injury
    Date Received
    January 14, 2018
    Date of Event
    June 1, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. POSSIBLE MODELS INCLUDE: VEDR01, VR D334VRG. 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: MAGNETIC RESONANCE IMAGING IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES: A SINGLE-CENTER PROSPECTIVE STUDY. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2017; 50(1):95-104.DOI: 10.1007/S10840-017-0262-6. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING PATIENTS RECEIVING MAGNETIC RESONANCE IMAGING (MRI) WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WAS A PATIENT THAT EXPERIENCED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). ADDITIONALLY IT WAS NOTED THAT ONE PATIENT EXPERIENCED WARMTH AT THE DEVICE SITE, AND ONE PATIENT EXPERIENCED IMAGING ARTIFACT DURING THE MRI SCAN RESULTING IN TERMINATION OF THE SCAN. THE STATUS OF THE DEVICES IS UNKNOWN. 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
    32239 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R