BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 6919879 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01492
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    December 29, 2015
    Report Date
    July 25, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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: ELECTROMAGNETIC INTERFERENCE OF ENDODONTIC EQUIPMENTS WITH CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE. JOURNAL OF DENTISTRY. 2016; 46:68-72.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPG). 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 ELECTROMAGNETIC INTERFERENCE (EMI) EXHIBITED FROM DENTAL EQUIPMENT. IT WAS NOTED THAT THE DEVICES WERE TESTED IN A SALINE SOLUTION AND NOT IMPLANTED IN PATIENTS. THERE WAS NO PATIENT INVOLVEMENT NOTED IN THE ARTICLE. 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
    703964 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1