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

Model Number ORCHESTRA PLUS LINK

Device Problem Wireless Communication Problem (3283)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Reportedly, the subject rf head was not recognized.The telemetry was lost.

Event Description

Reportedly, the subject rf head was not recognized.The telemetry was lost.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200123 - file-2019-03736 - analysis_and_closure_report_resp-2020-00094.Pdf].

• Brand Name: ORCHESTRA PLUS LINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L - CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 9361476
• MDR Text Key: 177174857
• Report Number: 1000165971-2019-00647
• Device Sequence Number: 1
• Product Code: MRM
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS LINK
• Device Catalogue Number: ORCHESTRA PLUS LINK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1