BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 7414124 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00415
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    January 1, 2015
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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. MODELS INCLUDE: ADAPTA, ADDRS1, VIRTUOSO, MAXIMO DR 7278, CONCERTO. 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: INTERFERENCE BETWEEN DENTAL ELECTRICAL DEVICES AND PACEMAKERS OR DEFIBRILLATORS: RESULTS FROM A PROSPECTIVE CLINICAL STUDY. JADA 146(2):121- 128. HTTP://DX.DOI.ORG/10.1016/J.ADAJ.2014.11.016. 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 ELECTROMAGNETIC INTERFERENCE (EMI) AND THE USE OF ELECTRICAL DENTAL DEVICES. 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 WITH IMPLANTABLE PULSE GENERATORS (IPG) AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) WERE EXPOSED TO ELECTRICAL DENTAL EQUIPMENT AT VARIOUS DISTANCES. THE ARTICLE REPORTS THAT NO SIGNIFICANT CLINICAL INTERFERENCE OCCURRED; HOWEVER, MINOR EMI AND TELEMETRY ISSUES WERE NOTED. 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
    261787 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1