BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 3830095 · Received May 23, 2014

    Report

    Report Number
    1000165971-2014-00297
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE INTERROGATION OF THE SUBJECT ICD, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED. THE PHYSICIAN WANTED TO PERFORM A CARDIOVERSION TO FREE THE PATIENT FROM AN ATRIAL FIBRILLATION. A MANUAL 34J-SHOCK WAS ATTEMPTED BUT AFTER A FEW SECONDS, NO SHOCK WAS DELIVERED AND THE "CHARGING" MESSAGE WAS SUBSTITUTED FOR "WAITING...". NOTHING ELSE HAPPENED. THE PATIENT WAS THEN PROVIDED WITH A EXTERNAL SHOCK THAT CONVERTED THE RHYTHM TO SINUSAL RHYTHM. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE ON (B)(6) 2014 AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE INTERROGATION OF THE SUBJECT ICD, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED. THE PHYSICIAN WANTED TO PERFORM A CARDIOVERSION TO FREE THE PATIENT FROM AN ATRIAL FIBRILLATION. A MANUAL 34J-SHOCK WAS ATTEMPTED BUT AFTER A FEW SECONDS, NO SHOCK WAS DELIVERED AND THE "CHARGING" MESSAGE WAS SUBSTITUTED FOR "WAITING...". NOTHING ELSE HAPPENED. THE PATIENT WAS THEN PROVIDED WITH A EXTERNAL SHOCK THAT CONVERTED THE RHYTHM TO SINUSAL RHYTHM. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE ON (B)(6) 2014 AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE INTERROGATION OF THE SUBJECT ICD, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED. THE PHYSICIAN WANTED TO PERFORM A CARDIOVERSION TO FREE THE PATIENT FROM AN ATRIAL FIBRILLATION. A MANUAL 34J-SHOCK WAS ATTEMPTED BUT AFTER A FEW SECONDS, NO SHOCK WAS DELIVERED AND THE "CHARGING" MESSAGE WAS SUBSTITUTED FOR "WAITING..." NOTHING ELSE HAPPENED. THE PATIENT WAS THEN PROVIDED WITH A EXTERNAL SHOCK THAT CONVERTED THE RHYTHM TO SINUSAL RHYTHM. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE ON 23 APRIL 2014 AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE INTERROGATION OF THE SUBJECT ICD, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED. THE PHYSICIAN WANTED TO PERFORM A CARDIOVERSION TO FREE THE PATIENT FROM AN ATRIAL FIBRILLATION. A MANUAL 34J-SHOCK WAS ATTEMPTED BUT AFTER A FEW SECONDS, NO SHOCK WAS DELIVERED AND THE "CHARGING" MESSAGE WAS SUBSTITUTED FOR "WAITING...". NOTHING ELSE HAPPENED. THE PATIENT WAS THEN PROVIDED WITH A EXTERNAL SHOCK THAT CONVERTED THE RHYTHM TO SINUSAL RHYTHM. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE ON (B)(6) 2014 AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308328 OVATIO DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM OVATIO DR 6550 S060223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention