MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY SR 2250; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SYMPHONY SR 2250

Device Problems Battery Problem (2885); Battery Problem: High Impedance (2947)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Bad estimation residual longevity.37 months in (b)(6) 2021 and today battery is close to ire(73lpm).

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Bad estimation residual longevity.37 months in 07 october 2021 and today battery is close to ire.

• Brand Name: SYMPHONY SR 2250
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM S.A.S; 98, rue maurice arnoux; montrouge 92120 ; FR 92120
• Manufacturer (Section G): SORIN CRM S.A.S; 98, rue maurice arnoux; montrouge 92120 ; FR 92120
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 15834373
• MDR Text Key: 304036577
• Report Number: 1000165971-2022-00528
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYMPHONY SR 2250
• Device Catalogue Number: SYMPHONY SR 2250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic