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

Model Number ORCHESTRA PLUS

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2015

Event Type  malfunction  

Event Description

High instability of rf signal was reported whatever the orchestra plus link position was versus the involved device (platinum device).Then, the rf connection was lost before performing an induction test.The inductive head should have been used in order to pursue the induction tests.

Manufacturer Narrative

Preliminary analysis revealed that the reported displayed error message was the result of an inadequate management of the software management when the real time data channel is lost due to perturbated rf just upon launching a test function.

Event Description

High instability of rf signal was reported whatever the orchestra plus link position was versus the involved device (platinum device).Then, the rf connection was lost before performing an induction test.The inductive head should have been used in order to pursue the induction tests.

Manufacturer Narrative

(b)(4).

Event Description

High instability of rf signal was reported whatever the orchestra plus link position was versus the involved device (platinum device).Then, the rf connection was lost before performing an induction test.The inductive head should have been used in order to pursue the induction tests.

• 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: 5266646
• MDR Text Key: 32915913
• Report Number: 1000165971-2015-00741
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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: 11/09/2015
• Event Location: Hospital
• Date Manufacturer Received: 02/02/2016
• 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