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 Problems Syncope (1610); Lethargy (2560); Syncope/Fainting (4411)

Event Date 11/18/2020

Event Type  Injury  

Event Description

Reportedly, in (b)(6) 2020, the estimated residual longevity displayed 32 months.During the follow-up performed on (b)(6) 2020, the estimated residual longevity displayed less than 5 months.The patient reported feeling sluggish and lethargic.A syncopal episode occurred approximately 1 week prior to the follow-up in (b)(6).The device replacement procedure is scheduled for (b)(6) 2020.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Event Description

Reportedly, in january 2020, the estimated residual longevity displayed 32 months.During the follow-up performed on 18 november 2020, the estimated residual longevity displayed less than 5 months.The patient reported feeling sluggish and lethargic.A syncopal episode occurred approximately 1 week prior to the follow-up in november.The device replacement procedure is scheduled for (b)(6) 2020.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Manufacturer Narrative

Preliminary analysis of the returned device revealed that electrical characteristics were within specifications.D6b and d9 updated.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, in (b)(6) 2020, the estimated residual longevity displayed 32 months.During the follow-up performed on (b)(6) 2020, the estimated residual longevity displayed less than 5 months.The patient reported feeling sluggish and lethargic.A syncopal episode occurred approximately 1 week prior to the follow-up in november.The device replacement procedure is scheduled for (b)(6) 2020.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

• 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: 11038639
• MDR Text Key: 222384826
• Report Number: 1000165971-2020-00819
• Device Sequence Number: 1
• Product Code: NVZ
• 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,Followup
• Report Date: 04/07/2021

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: 02/20/2008
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S060728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/24/2021; 03/23/2021
• Supplement Dates FDA Received: 03/19/2021; 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention