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

Model Number ORCHESTRA PLUS

Device Problem Issue With Displayed Error Message (2967)

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

Event Date 12/16/2015

Event Type  malfunction  

Event Description

It was not possible to interrogate a paradym rf device with the subject programmer and an orchestra plus link head updated with 2.50 version.An error message was displayed to the user stating about communication errors.Workaround was performed three times without success.It was necessary to replace the subject programmer in order to pursue the interrogation.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: 5352983
• MDR Text Key: 35672584
• Report Number: 1000165971-2016-00018
• 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
• Report Date: 12/16/2015

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 PLUS
• Device Catalogue Number: ORCHESTRA PLUS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/08/2016
• 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