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

Model Number ORCHESTRA PLUS

Device Problem Wireless Communication Problem (3283)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

Reportedly, when interrogating icds, the programmer recognizes rf (beep) but the session is not initiated.After a few seconds of waiting the manager screen is displayed and it is necessary to interrogate again.A second beep occurs and more waiting is necessary until finally the overview screen appears.The antenna was replaced with a new one, but the issue remained.

Manufacturer Narrative

¿ upon reception, o a reference icd platinium rf has been interrogated several times with both inductive and wireless telemetry, o no issues during the session have been observed neither on interrogation nor on performed test, o all three usb ports of the programmer have been tested with a rf antenna and a cpr3h telemetry head (which is connected to usb port), ¿ the reported issue could not be reproduced.¿ the root cause of the reported non-functioning of the rf telemetry could not be determined.¿ it can be suspected that the issue is related to o the distance between rf antenna and the interrogated device, o rf perturbation during the interrogation, o rf mode on the interrogated icds was off ¿ this case is retained and utilized for trend purposes.

Event Description

Reportedly, when interrogating icds, the programmer recognizes rf (beep) but the session is not initiated.After a few seconds of waiting the manager screen is displayed and it is necessary to interrogate again.A second beep occurs and more waiting is necessary until finally the overview screen appears.The antenna was replaced with a new one, but the issue remained.

• 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 reaumur; clamart 92140 ; FR 92140
• Manufacturer (Section G): KONTRON; sudetenstr. 8; kaufbeuren 87600 ; GM 87600
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue reaumur; clamart 92140 ; FR 92140
• MDR Report Key: 17539229
• MDR Text Key: 321283892
• Report Number: 1000165971-2023-00609
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic