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

Model Number ORCHESTRA

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

It was reported that the subject programmer displayed the message "operating system not found" on startup rendering it unusable.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20190304 - file-2018-03083 - analysis_and_closure_report_resp-2019-00298.Pdf].

Event Description

It was reported that the subject programmer displayed the message "operating system not found" on startup rendering it unusable.

• 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: 7901176
• MDR Text Key: 121564113
• Report Number: 1000165971-2018-00862
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA
• Device Catalogue Number: ORCHESTRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/20/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1