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

Model Number SYMPHONY DR 2550

Device Problem Low Battery (2584)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2017

Event Type  Injury  

Event Description

Reportedly, the device reached end of service prematurely based on the previous follow-up's residual longevity.The impedance was 6.68 kohms in june 2017.The device was replaced and will be returned.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, the device reached end of service prematurely based on the previous follow-up's residual longevity.The impedance was 6.68 kohms in (b)(6) 2017.The device was replaced.

Manufacturer Narrative

The preliminary analysis revealed that a normal battery depletion occurred.

Event Description

Reportedly, the device reached end of service prematurely based on the previous follow-up's residual longevity.The impedance was 6.68 kohms in (b)(6) 2017.The device was replaced.

• 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: 7174531
• MDR Text Key: 96706358
• Report Number: 1000165971-2018-00007
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

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: 11/05/2006
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S050510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/14/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 02/19/2018; 03/27/2018
• Supplement Dates FDA Received: 03/16/2018; 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2005
• 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): Hospitalization; Required Intervention