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

Model Number ORCHESTRA PLUS

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Event Description

Reportedly, it was impossible to reach the home page of this programmer, black screen with the message 'missing operatv4.5system' was displayed.

Event Description

Reportedly, it was impossible to reach the home page of this programmer, black screen with the message 'missing operatv4.5 system' was displayed.

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: 12246583
• MDR Text Key: 264101195
• Report Number: 1000165971-2021-00580
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 07/13/2021
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1