BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8537503 · Received April 22, 2019

    Report

    Report Number
    2182208-2019-00764
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    September 25, 2018
    Report Date
    April 22, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. MULTIPLE DEVICE MODELS WERE PROVIDED; HOWEVER, A ONE TO ONE CORRELATION CANNOT BE MADE. POSSIBLE MODELS INCLUDE ENTRUST, EVERA, MARQUIS, PROTECTA, SECURA, AND VIRTUOSO. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/6 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: "EFFICACY AND SAFETY OF NON-TRANSVENOUS CARDIOVERTER DEFIBRILLATORS IN INFANTS AND YOUNG CHILDREN." JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY (2019) 54:151¿159. HTTPS://DOI.ORG/10.1007/S10840-018-0451-Y. 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 DEFIBRILLATORS (ICDS), PACING LEADS, AND NON TRANSVENOUS SHOCK COILS. THE AUTHORS DISCUSSED APPLYING NON TRANSVENOUS ICD SYSTEMS TO INFANTS AND CHILDREN. THE INFORMATION SHOWED FOUR PATIENTS RECEIVED INAPPROPRIATE SHOCKS FOR RAPIDLY CONDUCTED ATRIAL TACHYCARDIA, FAR FIELD SENSING OF EXTERNAL ALTERNATING CURRENT AND LEAD FRACTURE OF A SUBCUTANEOUS SHOCK ELECTRODE. THERE WERE TWELVE PATIENTS THAT REQUIRED SURGICAL INTERVENTION DUE TO NON-TRANSVENOUS (NT) ICD MALFUNCTIONS CONSISTING OF SHOCK COIL DISLOCATIONS, SHOCK COIL FRACTURES, DEVICE DISLOCATION, PACING-SENSING LEAD FAILURE, AND PACING-SENSING LEAD INSULATION BREAKDOWN. THE STATUS/DISPOSITION OF THE PRODUCTS 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
    328427 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| L| R 6937 LEAD, 4968 LEAD