MAUDE Adverse Event Report: SORIN CRM SYMPHONY

Model Number SYMPHONY SR 2250

Device Problems Difficult to Interrogate (1331); Failure to Transmit Record (1521)

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

Event Date 01/13/2014

Event Type  Injury  

Event Description

Reportedly, upon device interrogation on (b)(6) 2014, the following error messages were displayed to user: "the first interrogation statistics backup failed" and "interrogation is stopped".The user could re-program some parameters afterwards but it was not possible to print them out.In addition, it was not possible to transfer the expert files of this pt from the programmer (serial number is unk).On (b)(6) 2014 and the following message was displayed: "the file or directory is corrupted and unreadable".

Manufacturer Narrative

This event concerns a device that was manufactured and used outside the united states.Analysis is pending.

• Brand Name: SYMPHONY
• Manufacturer (Section D): SORIN CRM; montrouge ; FR
• Manufacturer (Section G): SORIN CRM; 98 rue maurice arnoux; montrouge 9212 0; FR 92120
• Manufacturer Contact: e vincent ; 4 avenue reaumur; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3642191
• MDR Text Key: 4185491
• Report Number: 9610579-2014-00013
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2014,01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2006
• Device Model Number: SYMPHONY SR 2250
• Device Catalogue Number: SYMPHONY SR 2250
• Device Lot Number: M041210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2004
• 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
• Patient Outcome(s): Required Intervention