MAUDE Adverse Event Report: SORIN CRM OVATIO

Model Number OVATIO VR 6250

Device Problems Failure to Deliver Energy (1211); Under-Sensing (1661)

Patient Problems Ventricular Fibrillation (2130); Loss of consciousness (2418)

Event Date 12/20/2013

Event Type  Injury  

Event Description

Reportedly, no shock therapy was delivered by the icd during ventricular tachyarrhythmia.The pt was admitted following out of hospital cardiac arrest requiring external rescue.Patient remains unconscious.Device and lead (non-sorin) were reportedly expected to be explanted.Based on preliminary analysis results: a defibrillation lead issue or connection issue is suspected; no anomaly has been identified regarding the icd embedded software.Patient care recommendations have been provided (evaluation of the benefit of a re-intervention to check lead integrity and connection).

Manufacturer Narrative

This event concerns a device that was manufactured and used outside the united states.Analysis is pending.

• Brand Name: OVATIO
• Manufacturer (Section D): SORIN CRM; montrouge ; FR
• Manufacturer (Section G): SORIN CRM; 98 rue maurice arnoux; montrouge 9212 0; FR 92120
• Manufacturer Contact: e vincnt ; 4 avenue reaumur; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3601766
• MDR Text Key: 4094238
• Report Number: 9610579-2014-00006
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2010
• Device Model Number: OVATIO VR 6250
• Device Catalogue Number: OVATIO VR 6250
• Device Lot Number: S091015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/24/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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