MAUDE Adverse Event Report: SORIN CRM OVATIO; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number OVATIO VR 6250

Device Problems Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2014

Event Type  Injury  

Event Description

Ventricular arrhythmia was reportedly not detected and not treated by the icd during the night of (b)(6) 2014.According to external ecg, the rhythm was classified as ventricular tachycardia / ventricular fibrillation.Based on preliminary analysis results, the icd behaved in accordance with the programmed settings and with the specifications.Recommendations have been provided (evaluation of the benefit of reprogramming vt/vf detection parameters).

Event Description

Ventricular arrhythmia was reportedly not detected and not treated by the icd during the night of (b)(6) 2014.According to external ecg, the rhythm was classified as ventricular tachycardia / ventricular fibrillation.Based on preliminary analysis results, the icd behaved in accordance with the programmed settings and with the specifications.Recommendations have been provided (evaluation of the benefit of reprogramming vt/vf detection parameters).

• Brand Name: OVATIO
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4364073
• MDR Text Key: 5112380
• Report Number: 1000165971-2014-00727
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2009
• Device Model Number: OVATIO VR 6250
• Device Catalogue Number: OVATIO VR 6250
• Device Lot Number: S080128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/08/2014
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention