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

Model Number RHAPSODY + DR 2530

Device Problem Pacing Problem (1439)

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

Event Date 12/07/2020

Event Type  Injury  

Event Description

Reportedly, during a follow-up performed on (b)(6) 2020, it was observed that the battery impedance was 6.43kohms and the estimated residual longevity was 15 months.A pacemaker replacement procedure was then scheduled.It was confirmed during pre-procedure checks that the atrial and ventricular leads were programmed in bipolar pacing and sensing configurations.The device was left programmed in vvi mode, 30min-1 prior to the procedure.After the device was removed from the chest, long ventricular pauses were observed due to loss of pacing output, despite the fact that the ventricular lead was connected to the pacemaker and the pacemaker can was not being manipulated.The ventricular lead was connected to a pacing system analyzer (psa) and pacing output was regained.Normal ventricular lead impedance was measured and no evidence of noise oversensing on the ventricular channel was observed.No anomaly was observed during lead tests that were performed after the leads were connected to the newly implanted device.The patient was pacemaker-dependant.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2020, it was observed that the battery impedance was 6.43kohms and the estimated residual longevity was 15 months.A pacemaker replacement procedure was then scheduled.It was confirmed during pre-procedure checks that the atrial and ventricular leads were programmed in bipolar pacing and sensing configurations.The device was left programmed in vvi mode, 30min-1 prior to the procedure.After the device was removed from the chest, long ventricular pauses were observed due to loss of pacing output, despite the fact that the ventricular lead was connected to the pacemaker and the pacemaker can was not being manipulated.The ventricular lead was connected to a pacing system analyzer (psa) and pacing output was regained.Normal ventricular lead impedance was measured and no evidence of noise oversensing on the ventricular channel was observed.No anomaly was observed during lead tests that were performed after the leads were connected to the newly implanted device.The patient was pacemaker-dependant.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

Manufacturer Narrative

Electrical and mechanical characteristics of the returned device were within specifications.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2020, it was observed that the battery impedance was 6.43kohms and the estimated residual longevity was 15 months.A pacemaker replacement procedure was then scheduled.It was confirmed during pre-procedure checks that the atrial and ventricular leads were programmed in bipolar pacing and sensing configurations.The device was left programmed in vvi mode, 30min-1 prior to the procedure.After the device was removed from the chest, long ventricular pauses were observed due to loss of pacing output, despite the fact that the ventricular lead was connected to the pacemaker and the pacemaker can was not being manipulated.The ventricular lead was connected to a pacing system analyzer (psa) and pacing output was regained.Normal ventricular lead impedance was measured and no evidence of noise oversensing on the ventricular channel was observed.No anomaly was observed during lead tests that were performed after the leads were connected to the newly implanted device.The patient was pacemaker-dependant.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.

• 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: 11123262
• MDR Text Key: 225299448
• Report Number: 1000165971-2021-00209
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

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: 04/11/2008
• Device Model Number: RHAPSODY + DR 2530
• Device Catalogue Number: RHAPSODY + DR 2530
• Device Lot Number: S060926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/12/2021; 05/07/2021
• Supplement Dates FDA Received: 02/04/2021; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention