MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem Shock (2072)

Event Date 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device 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

Patient came to hospital following electrical storm and shocks delivery.Upon its interrogation, the physician was not able to have access to all the therapies delivered in device memories.Visualization of a part of all the shocks (5 out all) as well as all the arrhythmias had limited the choice of therapy programming which is a behavior according to specifications.However, review of these episodes by sorin product manager on november 07th 2016 raised a question regarding the end of the stored episode (a slow rhythm is expected or there are other criteria of end of episode).An explanation is required.

Manufacturer Narrative

Preliminary analysis showed that a magnet was placed on the subject device during arrhythmia, which explains the reported behavior.

Event Description

Patient came to hospital following electrical storm and shocks delivery.Upon its interrogation, the physician was not able to have access to all the therapies delivered in device memories.Visualization of a part of all the shocks (5 out all) as well as all the arrhythmias had limited the choice of therapy programming which is a behavior according to specifications.However, review of these episodes by sorin product manager on (b)(6) 2016 raised a question regarding the end of the stored episode (a slow rhythm is expected or there are other criteria of end of episode?).An explanation is required.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Patient came to hospital following electrical storm and shocks delivery.Upon its interrogation, the physician was not able to have access to all the therapies delivered in device memories.Visualization of a part of all the shocks (5 out all) as well as all the arrhythmias had limited the choice of therapy programming which is a behavior according to specifications.However, review of these episodes by sorin product manager on (b)(6) 2016 raised a question regarding the end of the stored episode (a slow rhythm is expected or there are other criteria of end of episode?).An explanation is required.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 6116146
• MDR Text Key: 60861747
• Report Number: 1000165971-2016-00742
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2016

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: 11/29/2013
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2016
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/14/2016; 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2012
• 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