MAUDE Adverse Event Report: SORIN CRM S.A.S SYMPHONY DR 2550; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SYMPHONY DR 2550

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

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

Unexpected early eol.Follow-up 11may2021 battery impedance 3,21 kohms next fu (b)(6) 2022 battery impedance >23kohms and eri/rrt.Technician wants to know if this fast depeletion is within all borders.Patient came back in standby mode.

Event Description

Unexpected early eol.Follow-up on (b)(6) 2021 battery impedance 3, 21 kohms next fu on (b)(6) 2022 battery impedance >23kohms and eri/rrt.Technician wants to know if this fast depeletion is within all borders.Patient came back in standby mode.

• Brand Name: SYMPHONY DR 2550
• 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: 14984688
• MDR Text Key: 304189719
• Report Number: 1000165971-2022-00324
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• 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