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

Model Number RHAPSODY D 2410

Device Problem Protective Measures Problem (3015)

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

Event Date 01/30/2023

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

At the follow up, an attempt to interrogate the pacemaker was performed and the programmer displayed the standby mode message.Given the situation, replacement of the pacemaker has been scheduled.An attempt will be made to return the device for analysis.

Event Description

At the follow up, an attempt to interrogate the pacemaker was performed and the programmer displayed the standby mode message.Given the situation, replacement of the pacemaker has been scheduled.An attempt will be made to return the device for analysis.

Manufacturer Narrative

An initial mdr report has been sent but the device is neither approved in the united states, nor similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Therefore, this mdr report is done to correct this information.

• 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
• 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 ; 146013665
• MDR Report Key: 16492577
• MDR Text Key: 311256189
• Report Number: 1000165971-2023-00127
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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 Model Number: RHAPSODY D 2410
• Device Catalogue Number: RHAPSODY D 2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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