BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7097686 · Received December 7, 2017

    Report

    Report Number
    2182208-2017-02158
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    January 1, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 54 YEARS OLD. 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: INAPPROPRIATE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCKS¿INCIDENCE, EFFECT, AND IMPLICATIONS FOR DRIVER LICENSING. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2017; 49(3):271-280. DOI: 10.1007/S10840-017-0272-4. THIS STUDY WAS REGISTERED IN THE (B)(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 THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE THERAPIES, WHICH RESULTED IN SYNCOPE. THERE WERE ALSO THE FOLLOWING ¿CAUSES¿ FOR INAPPROPRIATE THERAPIES: SVT, ¿ABNORMAL¿ SENSING, OVERSENSING, CHEST DISCOMFORT, LOSS OF CONSCIOUSNESS, AND ¿UNCLASSIFIED¿ EVENTS. VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF) WAS ALSO SEEN AS A RESULT OF THE INAPPROPRIATE THERAPIES. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. 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
    876357 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R