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

Model Number SYMPHONY D 2450

Device Problems Display or Visual Feedback Problem (1184); Battery Impedance Issue (2884)

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

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device 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

Reportedly, during a routine follow-up performed on (b)(6) 2018, the estimated residual longevity displayed was about 130 months, despite the fact that the subject pacemaker has been implanted for almost 10 years.Moreover, the scale of the battery curve displayed on the programmer screen ends at 10 years and does not adapt to the estimated residual longevity displayed.Preliminary analysis results confirmed the reported behavior.Based on available data, normal battery depletion occurred.

Manufacturer Narrative

Preliminary analysis results revealed that the displayed battery curve followed the device specifications.

Event Description

Reportedly, during a routine follow-up performed on 9 january 2018, the estimated residual longevity displayed was about 130 months, despite the fact that the subject pacemaker has been implanted for almost 10 years.Moreover, the scale of the battery curve displayed on the programmer screen ends at 10 years and does not adapt to the estimated residual longevity displayed.Preliminary analysis results confirmed the reported behavior.Based on available data, normal battery depletion occurred.

Event Description

Reportedly, during a routine follow-up performed on (b)(6) 2018, the estimated residual longevity displayed was about 130 months, despite the fact that the subject pacemaker has been implanted for almost 10 years.Moreover, the scale of the battery curve displayed on the programmer screen ends at 10 years and does not adapt to the estimated residual longevity displayed.Preliminary analysis results confirmed the reported behavior.Based on available data, normal battery depletion occurred.

• 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: 7236896
• MDR Text Key: 99087347
• Report Number: 1000165971-2018-00132
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 01/10/2018

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: 06/29/2009
• Device Model Number: SYMPHONY D 2450
• Device Catalogue Number: SYMPHONY D 2450
• Device Lot Number: S080103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/06/2018; 04/11/2018
• Supplement Dates FDA Received: 03/01/2018; 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2007
• 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