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

Model Number SYMPHONY DR 2550

Device Problem Data Problem (3196)

Patient Problem No Information (3190)

Event Date 12/03/2019

Event Type  malfunction  

Event Description

The pacing system was implanted on (b)(6) 2009.Reportedly, during a follow-up performed on (b)(6) 2019, it was observed that the estimated residual longevity was 109 months (+/- 5 months) with a battery impedance of 1.52 kohms and a magnet rate of 96 min-1.On (b)(6) 2019, a sales representative checked the patient files at the hospital and noticed that the percentage of ventricular pacing was 99%.An analysis of the pacemaker longevity was requested.

Event Description

The pacing system was implanted on (b)(6) 2009.Reportedly, during a follow-up performed on (b)(6) 2019, it was observed that the estimated residual longevity was 109 months (+/- 5 months) with a battery impedance of 1.52 kohms and a magnet rate of 96 min-1.On 5 december 2019, a sales representative checked the patient files at the hospital and noticed that the percentage of ventricular pacing was 99%.An analysis of the pacemaker longevity was requested.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 9530998
• MDR Text Key: 177566945
• Report Number: 1000165971-2019-00745
• 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: 01/30/2020

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: 10/18/2010
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S090327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1