MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2

Model Number PARADYM 2 DR 8552

Device Problem Inadequate User Interface (2958)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Reportedly, during scheduled follow-up of the subject icd on (b)(6) 2014, the orchestra programmer screen froze; the programmer had to be unplugged and rebooted to resume the follow-up.An explanation is requested.

Manufacturer Narrative

The device model involved in this mdr report is not approved in the u.S.; however, it is similar to paradym rf dr models approved under p980049.

Event Description

Reportedly, during scheduled follow-up of the subject icd on (b)(6) 2014, the orchestra programmer screen froze; the programmer had to be unplugged and rebooted to resume the follow-up.An explanation is requested.

• Brand Name: PARADYM 2
• 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: 3980157
• MDR Text Key: 4632051
• Report Number: 1000165971-2014-00442
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2015
• Device Model Number: PARADYM 2 DR 8552
• Device Catalogue Number: PARADYM 2 DR 8552
• Device Lot Number: 2809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• 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