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

Model Number SYMPHONY DR 2550

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Information (3190)

Event Date 05/23/2019

Event Type  Injury  

Event Description

Reportedly, an estimated residual longevity of 14 months was displayed on the programmer on (b)(6) 2018.However, during the follow-up performed on (b)(6) 2019, the device was found to have reached its recommended replacement time (rrt).Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Event Description

Reportedly, an estimated residual longevity of 14 months was displayed on the programmer on 8 november 2018.However, during the follow-up performed on (b)(6) 2019, the device was found to have reached its recommended replacement time (rrt).Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Manufacturer Narrative

Please refer to the attached analysis report.D6 corrected.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM S.A.S; 98 rue maurice arnoux; .; montrouge 92120 ; FR 92120
• MDR Report Key: 10837348
• MDR Text Key: 216184902
• Report Number: 1000165971-2020-00733
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2009
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: M071121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2020
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention