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

Model Number ORCHESTRA

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 07/23/2020

Event Type  malfunction  

Event Description

Reportedly, an interrogation of a pacemaker was tried on (b)(6) 2020.The subject programmer took more than 30 minutes to load patient data.The programmer showed messages of telemetry error even though the associated head had green light.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, an interrogation of a pacemaker was tried on (b)(6) 2020.The subject programmer took more than 30 minutes to load patient data.The programmer showed messages of telemetry error even though the associated head had green light.

• 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: 10418901
• MDR Text Key: 203858987
• Report Number: 1000165971-2020-00555
• 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
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA
• Device Catalogue Number: ORCHESTRA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1