BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINIUM

    MDR report key: 6662795 · Received June 23, 2017

    Report

    Report Number
    1000165971-2017-00509
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 2, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION COMPLICATION THAT WAS STABILIZED DURING THE IMPLANTATION PROCEDURE. DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2016, THE SUBJECT ICD SHOWED NORMAL ELECTRICAL PERFORMANCES. ON (B)(6) 2017, EPISODES OF NOISE WERE RECORDED IN THE DEVICE MEMORY. A SHOCK WAS DELIVERED ON (B)(6) 2017 (REPORTEDLY DURING AN EFFORT). THE VENTRICULAR PACING THRESHOLD INCREASED FROM 0.75 TO 1.5V. VENTRICULAR SENSITIVITY HAS BEEN SET TO 0.8MV, AND TACHYCARDIA DETECTION ZONE WAS REPROGRAMMED AS FOLLOWS: ONE SINGLE FAST VT/VF ZONE (190-240 BPM), PERSISTENCE OF 16 CYCLES WITH 1 ATP BURST + 4 SHOCKS. X-RAYS WERE PERFORMED, AND NO LEAD DISLODGMENT WAS REPORTEDLY OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443948 PLATINIUM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM VR 1240 S0141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention