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

Model Number SYMPHONY DR 2550

Device Problem Low Battery (2584)

Patient Problem No Information (3190)

Event Date 11/17/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, during a follow-up, the programmer displayed a residual longevity of around 19 months.On (b)(6) 2017, during another follow-up, this pacemaker was found in end of life and, consequently, the device was replaced.The device will be returned.

Manufacturer Narrative

The analysis revealed a normal battery depletion.

Event Description

On (b)(6) 2017, during a follow-up, the programmer displayed a residual longevity of around 19 months.On (b)(6) 2017, during another follow-up, this pacemaker was found in end of life and, consequently, the device was replaced.The device will be returned.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, during a follow-up, the programmer displayed a residual longevity of around 19 months.On (b)(6) 2017, during another follow-up, this pacemaker was found in end of life and, consequently, the device was replaced.The device will be returned.

• 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: 7125168
• MDR Text Key: 95174355
• Report Number: 1000165971-2017-00930
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 11/23/2017

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: 01/25/2009
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S070706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/23/2017
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 01/02/2018; 02/12/2018
• Supplement Dates FDA Received: 01/24/2018; 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2007
• 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
• Patient Outcome(s): Required Intervention