MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY INTENSIA

Model Number INTENSIA DR 154

Device Problem Telemetry Discrepancy (1629)

Patient Problem Not Applicable (3189)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, on (b)(6) 2015, the subject device was being checked as usual at the operating room prior to implant, with an orchestra+.Telemetry was working properly but was lost at a certain moment.Despite several attempts to establish communications with different programmers and programming heads, no telemetry could have been established with the subject device.Therefore, telemetry was always working with some other icds available with the different programmers and programming heads used, excluding an issue on the programmer level and/or on the programming head level used.Preliminary analysis showed that the telemetry was working fine at the beginning but was lost upon reprogramming of patient data.A hardware issue was suspected.Further investigations are ongoing.

Event Description

Reportedly, on (b)(6) 2015, the subject device was being checked as usual at the operating room prior to implant, with an orchestra+.Telemetry was working properly but was lost at a certain moment.Despite several attempts to establish communications with different programmers and programming heads, no telemetry could have been established with the subject device.Therefore, telemetry was always working with some other icds available with the different programmers and programming heads used, excluding an issue on the programmer level and/or on the programming head level used.Preliminary analysis showed that the telemetry was working fine at the beginning but was lost upon reprogramming of patient data.A hardware issue was suspected.Further investigations are ongoing.

• Brand Name: INTENSIA
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5182863
• MDR Text Key: 30252801
• Report Number: 1000165971-2015-00651
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2015
• Device Model Number: INTENSIA DR 154
• Device Catalogue Number: INTENSIA DR 154
• Device Lot Number: 2852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/09/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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