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

Model Number ORCHESTRA

Device Problem Issue With Displayed Error Message (2967)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Event Description

Reportedly, the subject programmer displays an unknown window and during patient follow-up it was shutdown unexpectedly.There were no patient consequences.Investigations are required.

Event Description

Reportedly, the subject programmer displays an unknown window and during patient follow-up it was shutdown unexpectedly.There were no patient consequences.Investigations are required.

• 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
• Manufacturer (Section G): GESPAC 18, CHEMIN DES AULX CH-1228 GEN¿VE SWITZLERLAND; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6050127
• MDR Text Key: 58191787
• Report Number: 1000165971-2016-00651
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP980049
• 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
• Device Catalogue Number: ORCHESTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2016
• Event Location: Hospital
• Date Manufacturer Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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