MAUDE Adverse Event Report: SORIN CRM SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SYMPHONY DR 2550

Device Problem Failure to Transmit Record (1521)

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

Event Date 03/13/2014

Event Type  malfunction  

Event Description

Reportedly, aida (follow-up data stored in device memory) was not available.An explanation is requested.It should be noted the same event was already reported in 2013 (mdr# 9610579-2013-00035).

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, aida (follow-up data stored in device memory) was not available.An explanation is requested.It should be noted the same event was already reported in 2013 (mdr# 9610579-2013-00035).

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; clamart 9214 0; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; 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: 3745757
• MDR Text Key: 4480986
• Report Number: 1000165971-2014-00200
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/13/2014

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: 07/15/2011
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S100115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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