MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY; DUAL-CHAMBER PACEMAKER, DEMAND

Model Number RHAPSODY D 2410

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

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

The subject pacemaker was implanted on (b)(6) 2004.Reportedly, on (b)(6) 2018, the magnet rate was 95 min-1, the battery impedance was 3.9 kohms and the estimated residual longevity was 42 months.On (b)(6) 2019, the magnet rate was 93 min-1, the battery impedance was 5.19 kohms and the estimated residual longevity was 27 months.On (b)(6) 2020, the pacemaker was found in vvi mode with a magnet rate of 73 min-1 and a battery impedance of 23.05 kohms.The pacemaker was explanted on (b)(6) 2020.

Event Description

The subject pacemaker was implanted on (b)(6) 2004.Reportedly, on (b)(6) 2018, the magnet rate was 95 min-1, the battery impedance was 3.9 kohms and the estimated residual longevity was 42 months.On (b)(6) 2019, the magnet rate was 93 min-1, the battery impedance was 5.19 kohms and the estimated residual longevity was 27 months.On (b)(6)2020, the pacemaker was found in vvi mode with a magnet rate of 73 min-1 and a battery impedance of 23.05 kohms.The pacemaker was explanted on (b)(6) 2020.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: SYMPHONY
• Type of Device: DUAL-CHAMBER PACEMAKER, DEMAND
• Manufacturer (Section D): SORIN CRM S.A.S; 98 rue maurice arnoux; .; montrouge, 92120 ; FR 92120
• MDR Report Key: 11326072
• MDR Text Key: 233741668
• Report Number: 1000165971-2021-00287
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: 01/21/2006
• Device Model Number: RHAPSODY D 2410
• Device Catalogue Number: RHAPSODY D 2410
• Device Lot Number: M040715
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/20/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/14/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1