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

Model Number ORCHESTRA PLUS LINK

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  malfunction  

Event Description

Reportedly, during the implantation of a crt-d on (b)(6) 2020 and after measurements were performed with the newly implanted device inside the pocket, rf connection was lost between the crt-d and the subject orchestra plus link and could not be recovered.

Manufacturer Narrative

Expertise files analysis confirmed the reported loss of rf connection between the crt-d and the orchestra plus link.Its root cause could not be determined with certainty, but the rf communication was most likely disturbed by environmental conditions (nearby appliances/objects).No issue is suspected on the crt-d nor on the orchestra plus link.

Event Description

Reportedly, during the implantation of a crt-d on (b)(6) 2020 and after measurements were performed with the newly implanted device inside the pocket, rf connection was lost between the crt-d and the subject orchestra plus link and could not be recovered.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during the implantation of a crt-d on (b)(6) 2020 and after measurements were performed with the newly implanted device inside the pocket, rf connection was lost between the crt-d and the subject orchestra plus link and could not be recovered.

• 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: 10477849
• MDR Text Key: 206197060
• Report Number: 1000165971-2020-00579
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1