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

Model Number ORCHESTRA PLUS

Device Problem Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

Reportedly, during an incoming inspection, it was observed that the subject programmer automatically shut down after a normal boot up.

Event Description

Reportedly, during an incoming inspection, it was observed that the subject programmer automatically shut down after a normal boot up.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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: 9516044
• MDR Text Key: 177184188
• Report Number: 1000165971-2019-00735
• 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: 09/01/2020

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: Other
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1