BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4829729 · Received June 9, 2015

    Report

    Report Number
    2182208-2015-01872
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 12, 2015
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: ¿NON-RESPONSE TO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IN A POST-INFARCTION PATIENT WITH RECURRENT VENTRICULAR TACHYCARDIA AFTER CATHETER ABLATION. CHIN MED J 2015;128:415-6.¿ WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4)

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ARTICLE NOTED THAT THE PATIENT REQUIRED A RADIOFREQUENCY CATHETER ABLATION (RFCA) FOR VENTRICULAR TACHYCARDIA (VT). TWO WEEKS AFTER THE RFCA, VTS WERE DETECTED BY ELECTROCARDIOGRAM MONITORING, BUT WERE NOT DETECTED BY THE PATIENT'S ICD. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372770 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, PLC MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention