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); Issue With Displayed Error Message (2967)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

It was reported that error messages were displayed while using the subject programmer.Indeed, the following message "failed to access manage core" was displayed.A workaround (crtl+alt+del and f8) was performed without success.Preliminary analysis revealed that the issue resulted from an ongoing process that was taking 99% of the central processing unit time.It was due to a sudden shutdown while the system was hibernating.The subject programmer was returned for repair.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

It was reported that error messages were displayed while using the subject programmer.Indeed, the following message "failed to access manage core" was displayed.A work around (crtl+alt+del and f8) was performed without success.Preliminary analysis revealed that the issue resulted from an ongoing process that was taking 99% of the central processing unit time.It was due to a sudden shutdown while the system was hibernating.The subject programmer was returned 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): 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: 5939257
• MDR Text Key: 54754624
• Report Number: 1000165971-2016-00548
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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: 08/23/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/23/2016
• Date Manufacturer Received: 09/13/2016
• 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