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

Model Number ORCHESTRA PLUS

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

It was reported that during the upgrade performed on (b)(6) 2015, a message was displayed stating the following ¿error during file copy - source file altered¿.The upgrade was re-launched yet again and was executed successfully.A confirmation about the good functioning of the programmer is required.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the upgrade performed on (b)(6) 2015, a message was displayed stating the following "error during file copy - source file altered." the upgrade was re-launched yet again and was executed successfully.A confirmation about the good functioning of the programmer 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 9214 0; FR 92140
• Manufacturer (Section G): KONTRON SUDETENSTR. 8 87600 KAUFBEUREN GERMANY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4733185
• MDR Text Key: 5586141
• Report Number: 1000165971-2015-00258
• Device Sequence Number: 1
• Product Code: KRG
• 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: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• 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?: No
• Distributor Facility Aware Date: 04/03/2015
• Date Manufacturer Received: 06/23/2015
• 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