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 09/27/2016

Event Type  malfunction  

Event Description

It was reported that during an attempt to interrogate a pacemaker (kora 250 device) with the subject programmer installed with version 2.54, an error message was displayed stating that a problem will occur with the implantable device if the interrogation is pursued.This message was only reported by the user and was not seen upon interrogating another implantable device.Due to the issue in smartview 2.54 installation, preliminary analysis revealed the necessity to return back the subject programmer for repair.

Event Description

It was reported that during an attempt to interrogate a pacemaker (kora 250 device) with the subject programmer installed with version 2.54, an error message was displayed stating that a problem will occur with the implantable device if the interrogation is pursued.This message was only reported by the user and was not seen upon interrogating another implantable device.Due to the issue in smartview 2.54 installation, preliminary analysis revealed the necessity to return back the subject programmer for repair.

• 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: 6029730
• MDR Text Key: 57796688
• Report Number: 1000165971-2016-00633
• Device Sequence Number: 1
• Product Code: KRG
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/27/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• 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