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 Problem Palpitations (2467)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Reportedly, on (b)(6) 2019, a battery impedance of 4.4 kohms and an estimated residual longevity of 36 months were displayed on the programmer.However, during the follow-up performed on (b)(6) 2020, the device was found to have reached its recommended replacement time (rrt).The pacemaker switched in backup mode, pacing in vvi mode at 70 min-1.The patient reported palpitations and shortness of breath.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.The electrical characteristics of the returned device conformed to established specifications.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, on (b)(6) 2019, a battery impedance of 4.4 kohms and an estimated residual longevity of 36 months were displayed on the programmer.However, during the follow-up performed on (b)(6) 2020, the device was found to have reached its recommended replacement time (rrt).The pacemaker switched in backup mode, pacing in vvi mode at 70 min-1.The patient reported palpitations and shortness of breath.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.The electrical characteristics of the returned device conformed to established specifications.

• 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: 10861029
• MDR Text Key: 216891305
• Report Number: 1000165971-2020-00741
• 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: 02/09/2021

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: 09/16/2008
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S070227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention