MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ORCHESTRA PLUS LINK; PROGRAMMER, PACEMAKER

Model Number ORCHESTRA PLUS LINK

Device Problems Loose or Intermittent Connection (1371); Wireless Communication Problem (3283)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

Preliminary analysis showed normal functioning of the returned device.

Event Description

Reportedly, communication is often lost while performing icd follow-ups, and it is necessary to position the head on the patient to restore proper communication.Preliminary analysis showed normal functioning of the returned device.

Manufacturer Narrative

Upon reception, the orchestra plus link was tested and the reported behavior was not reproduced: normal communication was observed with a reference icd.The reported intermittent communication was most probably related to bad rf environmental conditions (non-optimized positioning of the rf head) and/or disturbances caused by nearby appliances/objects.As explained in the orchestra plus link manual, the orchestra plus link can be subject to disturbances from other products in the vicinity which emit electromagnetic interferences.No anomaly is suspected on the rf head.

Event Description

Reportedly, communication is often lost while performing icd follow-ups, and it is necessary to position the head on the patient to restore proper communication.

• Brand Name: ORCHESTRA PLUS LINK
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 15637363
• MDR Text Key: 302092057
• Report Number: 1000165971-2022-00456
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• 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