MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY INTENSIA; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number INTENSIA VR 124

Device Problem Issue With Displayed Error Message (2967)

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

Event Date 09/02/2017

Event Type  Injury  

Event Description

Reportedly, the patient was followed up on (b)(6) 2017, following the delivery of a shock on (b)(6) 2017.Therapy was delivered correctly.During icd interrogation on (b)(6) 2017, two warning messages were displayed, indicating inconsistent dates (warning dated (b)(6) 2014, before implantation and warning dated (b)(6) 2019, in the future).The icd was interrogated again on (b)(6) 2017; normal operation was observed and no warning message was displayed.

• Brand Name: INTENSIA
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• MDR Report Key: 6915746
• MDR Text Key: 88220327
• Report Number: 1000165971-2017-00730
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INTENSIA VR 124
• Device Catalogue Number: INTENSIA VR 124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization