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

Model Number ORCHESTRA PLUS

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 02/17/2020

Event Type  malfunction  

Event Description

Reportedly, the subject programmer has a burning smell.

Manufacturer Narrative

Please refer to the attached investigation report.- attachment: [20200519 - file-2020-00484 - analysis_and_closure_report_resp-2020-00532.Pdf].

Event Description

Reportedly, the subject programmer has a burning smell.

• 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: 9828657
• MDR Text Key: 183482956
• Report Number: 1000165971-2020-00297
• 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: 05/19/2020

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: 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: 02/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2020
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1