BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINIUM

    MDR report key: 6202116 · Received December 23, 2016

    Report

    Report Number
    1000165971-2016-00851
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 23, 2016
    Report Date
    June 26, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY, THE SECOND HARDWARE RESET TO CORRECT THE ESTIMATION OF THE RESIDUAL LONGEVITY DISPLAYED BY THE PROGRAMMER WILL BE PERFORMED ON 1 JUNE 2018.

    Additional Manufacturer Narrative · 1

    THE HARDWARE RESET PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2018.

    Description of Event or Problem · 1

    REPORTEDLY, AN INTEGRITY SYSTEM ALERT (WARNING [A3]) WAS RAISED ON (B)(6) 2016 UPON INTERROGATION OF THE SUBJECT ICD, IMPLANTED ON (B)(6) 2016 WITH A REPLACEMENT OF THE RIGHT VENTRICULAR LEAD. SINCE THEN, THE ICD WAS RE-INTERROGATED BUT THE ALERT DISAPPEARED.

    Description of Event or Problem · 1

    REPORTEDLY, AN INTEGRITY SYSTEM ALERT (WARNING ) WAS RAISED ON (B)(6) 2016 UPON INTERROGATION OF THE SUBJECT ICD, IMPLANTED ON (B)(6) 2016 WITH A REPLACEMENT OF THE RIGHT VENTRICULAR LEAD. SINCE THEN, THE ICD WAS RE-INTERROGATED BUT THE ALERT DISAPPEARED.

    Description of Event or Problem · 1

    REPORTEDLY, AN INTEGRITY SYSTEM ALERT (WARNING [A3]) WAS RAISED ON (B)(6) 2016 UPON INTERROGATION OF THE SUBJECT ICD, IMPLANTED ON (B)(6) 2016 WITH A REPLACEMENT OF THE RIGHT VENTRICULAR LEAD. SINCE THEN, THE ICD WAS RE-INTERROGATED BUT THE ALERT DISAPPEARED.

    Description of Event or Problem · 1

    REPORTEDLY, AN INTEGRITY SYSTEM ALERT (WARNING) WAS RAISED ON (B)(6) 2016 UPON INTERROGATION OF THE SUBJECT ICD, IMPLANTED ON (B)(6) 2016 WITH A REPLACEMENT OF THE RIGHT VENTRICULAR LEAD. SINCE THEN, THE ICD WAS RE-INTERROGATED BUT THE ALERT DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852663 PLATINIUM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION DTB SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM SONR CRT-D 1841 S0122

    Patients

    Seq Age Sex Outcome Treatment
    1