MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA; PROGRAMMER, PACEMAKER

Model Number ORCHESTRA PLUS

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Information (3190)

Event Date 03/16/2020

Event Type  malfunction  

Event Description

Reportedly, a freeze of the programmer occurred during a follow-up.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, a freeze of the programmer occurred during a follow-up.

• Brand Name: ORCHESTRA
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 9942308
• MDR Text Key: 187602552
• Report Number: 1000165971-2020-00351
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1