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

Model Number ORCHESTRA PLUS

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/15/2015

Event Type  malfunction  

Event Description

It was reported that the subject programmer installed with smartview version 2.44 could not be used.A message regarding the initialisation head was displayed permanently.Reboot of the programmer did not resolve the issue.An explanation is required.

Event Description

It was reported that the subject programmer installed with smartview version 2.44 could not be used.A message regarding the initialisation head was displayed permanently.Reboot of the programmer did not resolve the issue.An explanation is required.

Manufacturer Narrative

Preliminary analysis showed that a sudden shutdown of the programmer had most certainly caused the database corruption leading to the reported behaviour.

Event Description

It was reported that the subject programmer installed with smartview version 2.44 could not be used.A message regarding the initialisation head was displayed permanently.Reboot of the programmer did not resolve the issue.An explanation is 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): KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY; 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: 4924674
• MDR Text Key: 6051720
• Report Number: 1000165971-2015-00436
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORCHESTRA PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2015
• Event Location: Hospital
• Date Manufacturer Received: 10/12/2015
• 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