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 Electric Shock (2554)

Event Date 11/12/2015

Event Type  malfunction  

Event Description

Acute cardioversion was performed on (b)(6) 2015, due to ventricular fibrillation induced by exercise.After cardioversion, no trace of this vf episode was found in the device memories.Nevertheless, pacemaker seems to work properly.Preliminary analysis results showed normal behavior of the pacemaker after the cardioversion.

Manufacturer Narrative

(b)(4).

Event Description

Acute cardioversion was performed on (b)(6) 2015, due to ventricular fibrillation induced by exercise.After cardioversion, no trace of this vf episode was found in the device memories.Nevertheless, pacemaker seems to work properly.Preliminary analysis results showed normal behavior of the pacemaker after the cardioversion.

Manufacturer Narrative

The reported event is confirmed.The most probable hypothesis to explain why no ventricular run episode is recorded in the device memories is that the pacemaker did not detect any tachycardia, since events sensed by the pacemaker did not meet the criteria required for detecting and/or recording a ventricular run episode.

Event Description

Acute cardioversion was performed on (b)(6) 2015, due to ventricular fibrillation induced by exercise.After cardioversion, no trace of this vf episode was found in the device memories.Nevertheless, pacemaker seems to work properly.Preliminary analysis results showed normal behavior of the pacemaker after the cardioversion.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; 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: 5276477
• MDR Text Key: 33523868
• Report Number: 1000165971-2015-00751
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2015

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: 07/17/2009
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S080110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/12/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2016; 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2007
• 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