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

Model Number RHAPSODY + DR 2530

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 12/30/2020

Event Type  Injury  

Event Description

The subject pacemaker was implanted on (b)(6) 2008.Reportedly, on (b)(6) 2019, the magnet rate was 95 min-1, the battery impedance was 3.46 kohms and the estimated residual longevity was 45 months.On (b)(6) 2020, the magnet rate was 94 min-1, the battery impedance was 4.61 kohms and the estimated residual longevity was 36 months.On (b)(6) 2020, the magnet rate was 90 min-1, the battery impedance was 7.34 kohms and no estimated residual longevity was displayed.The pacemaker was explanted on (b)(6) 2021.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The subject pacemaker was implanted on (b)(6) 2008.Reportedly, on (b)(6) 2019, the magnet rate was 95 min-1, the battery impedance was 3.46 kohms and the estimated residual longevity was 45 months.On (b)(6) 2020, the magnet rate was 94 min-1, the battery impedance was 4.61 kohms and the estimated residual longevity was 36 months.On (b)(6)2020, the magnet rate was 90 min-1, the battery impedance was 7.34 kohms and no estimated residual longevity was displayed.The pacemaker was explanted on (b)(6) 2021.

• 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: 11326076
• MDR Text Key: 233739648
• Report Number: 1000165971-2021-00288
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2009
• Device Model Number: RHAPSODY + DR 2530
• Device Catalogue Number: RHAPSODY + DR 2530
• Device Lot Number: S080415
• 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
• Patient Outcome(s): Required Intervention