BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3861213 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11241
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ABDOMINAL STENT GRAFT X 4 2013 (B)(6); 4076 LEAD 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED APPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR RECURRENT VENTRICULAR TACHYCARDIA (VT) WHICH DID NOT CONVERT THE PATIENT¿S RHYTHM. THE PATIENT WAS ADMITTED FOR EP STUDY AND ABLATION. DURING ABLATION PROCESS PATIENT HAD ANOTHER EPISODE OF VT THAT WAS NOT PACED TERMINABLE BY THE PACER. THE PATIENT WAS STARTED ON INTRAVENOUS MEDICATION. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340196 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R 693565 LEAD