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

Model Number ORCHESTRA PLUS

Device Problem Failure to Transmit Record (1521)

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

Event Date 07/13/2016

Event Type  malfunction  

Event Description

Reportedly, during a routine follow-up of a pacemaker (reply dr 101zk03d) with the subject programmer, the ventricular threshold test could not be stopped with the spacebar key.Note that the patient is device-dependent.No issue was observed during other real time tests performed on that day (e.G., atrial threshold test, sensing test).

Manufacturer Narrative

Preliminary analysis showed that the failure was originated at operating system level (windows).The issue is not reproducible (negligible probability to happen again).Both from hardware and software point of view, the programmer is fully functional and does not need for repair.

Event Description

Reportedly, during a routine follow-up of a pacemaker (reply dr (b)(4)) with the subject programmer, the ventricular threshold test could not be stopped with the spacebar key.Note that the patient is device-dependent.No issue was observed during other real time tests performed on that day (e.G., atrial threshold test, sensing test).

Event Description

Reportedly, during a routine follow-up of a pacemaker (b)(4) with the subject programmer, the ventricular threshold test could not be stopped with the spacebar key.Note that the patient is device-dependent.No issue was observed during other real time tests performed on that day (e.G., atrial threshold test, sensing test).

• 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: 5853867
• MDR Text Key: 52285578
• Report Number: 1000165971-2016-00473
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/13/2016
• Event Location: Hospital
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1