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

Model Number PARADYM SONR CRT-D TRI-V

Device Problems Failure to Transmit Record (1521); Device Operates Differently Than Expected (2913)

Patient Problem Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 12/03/2015

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

It was reported that on (b)(6) 2015, this subject device was taken in charge by the (b)(6) because of acute pulmonary edema.Upon interrogating this device, no arrhythmia episode was found recorded in device memories.Same observation was also reported upon interrogating the subject device in its implantation center.However, the heart rate curve showed a sustained arrhythmia at 150min-1 (above the cut-off rate of the vt zone).An investigation is required, as well as recommendation of re-programming in order to record arrhythmia episode.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2015, this patient was taken in charge by an ambulance because of acute pulmonary edema.Upon interrogating of the subject device, no arrhythmia episode was found recorded in device memories.Same observation was also reported upon interrogating the device in its implantation center.However, the heart rate curve showed a sustained arrhythmia at 150min-1 (above the cut-off rate of the vt zone).An investigation is required, as well as recommendation of re-programming in order to record arrhythmia episode.

• Brand Name: PARADYM
• 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: 5346395
• MDR Text Key: 35552907
• Report Number: 1000165971-2016-00008
• Device Sequence Number: 1
• Product Code: MRM
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2016
• Device Model Number: PARADYM SONR CRT-D TRI-V
• Device Catalogue Number: PARADYM SONR CRT-D TRI-V
• Device Lot Number: S0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/11/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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