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

Event Date 12/02/2020

Event Type  Injury  

Event Description

Reportedly, premature battery depletion occurred compared to the estimated residual longevity displayed by the programmer (on (b)(6) 2019 it was 41 months, on (b)(6) 2019 it was 21 months and on (b)(6) 2020 the device had reached the recommended replacement time (rrt)).

Event Description

Reportedly, premature battery depletion occurred compared to the estimated residual longevity displayed by the programmer (on (b)(6) 2019 it was 41 months, on (b)(6) 2019 it was 21 months and on (b)(6) 2020 the device had reached the recommended replacement time (rrt)).

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: 11309280
• MDR Text Key: 231212760
• Report Number: 1000165971-2021-00274
• 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
• Report Date: 05/20/2021

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: 01/17/2008
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: S060705
• 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: 02/10/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention