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

Model Number PARADYM SONR CRT-D 8770

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

Reportedly, some inconsistencies were observed in the follow-up data stored in device memory (aida): a total time in mode switch (algorithm to prevent high rate pacing in the ventricular channel in case of atrial arrhythmias) of 3 minutes and 08 seconds was displayed in the statistics data but two mode switch episodes were recorded in device memory with the durations of (4 minutes and 52 seconds) and (5 minutes and 10 seconds).An analysis is requested.

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, some inconsistencies were observed in the follow-up data stored in device memory (aida): a total time in mode switch (algorithm to prevent high rate pacing in the ventricular channel in case of atrial arrhythmias) of 3 minutes and 08 seconds was displayed in the statistics data but two mode switch episodes were recorded in device memory with the durations of (4 minutes and 52 seconds) and (5 minutes and 10 seconds).An analysis is requested.

• Brand Name: PARADYM
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 4763048
• MDR Text Key: 5785148
• Report Number: 1000165971-2015-00292
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2015
• Device Model Number: PARADYM SONR CRT-D 8770
• Device Catalogue Number: PARADYM SONR CRT-D 8770
• Device Lot Number: 2827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• 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