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

Model Number ORCHESTRA PLUS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

Event Description

The programmer head could not be identified by the subject programmer.Same issue was observed with other programmer heads plugged to the same programmer.Investigations are required.

Event Description

The programmer head could not be identified by the subject programmer.Same issue was observed with other programmer heads plugged to the same programmer.Investigations are required.

Manufacturer Narrative

In-depth investigations were performed and revealed that the central processor unit (cpu) board of the programmer was defective: polluted connectors were found on this cpu board.The link between the observed defect and the reported behavior could not be confirmed with certainty.

Event Description

The programmer head could not be identified by the subject programmer.Same issue was observed with other programmer heads plugged to the same programmer.Investigations are required.

Event Description

The programmer head could not be identified by the subject programmer.Same issue was observed with other programmer heads plugged to the same programmer.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): 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: 5447719
• MDR Text Key: 39079637
• Report Number: 1000165971-2016-00097
• Device Sequence Number: 1
• Product Code: DTB
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/08/2016
• Event Location: Outpatient Diagnostic Facility
• Date Manufacturer Received: 06/22/2016
• 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