MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS LINK; UNKNOWN

Model Number ORCHESTRA PLUS LINK

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Event Description

The subject orchestra plus link head stopped working during implantation.The defibrillator and the programmer involved were upgraded with the smartview version (b)(4).The defibrillator (platinum 616da114) was interrogated twice before implantation in order to access the buttons "reset" and "resfresh episodes." replacing the head allowed to pursue the implantation process and to induce ventricular fibrillation.It should be noted that there was no issue in interrogating the defibrillator before implantation, upgrading the defibrillator and programming were possible.Investigations are required.

Manufacturer Narrative

(b)(4).

Event Description

The subject orchestra plus link head stopped working during implantation.The defibrillator and the programmer involved were upgraded with the smartview version (b)(4).The defibrillator (platinum 616da114) was interrogated twice before implantation in order to access the buttons "reset" and "refresh episodes." replacing the head allowed to pursue the implantation process and to induce ventricular fibrillation.It should be noted that there was no issue in interrogating the defibrillator before implantation, upgrading the defibrillator and programming were possible.Investigations are required.

• Brand Name: ORCHESTRA PLUS LINK
• Type of Device: UNKNOWN
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• MDR Report Key: 6050126
• MDR Text Key: 58186645
• Report Number: 1000165971-2016-00650
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• 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: 09/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2016
• Event Location: Hospital
• Date Manufacturer Received: 09/20/2017
• 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: Reuse
• Patient Sequence Number: 1