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

Model Number ORCHESTRA PLUS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem Ventricular Tachycardia (2132)

Event Date 03/15/2016

Event Type  malfunction  

Event Description

During the night between (b)(6) 2016, the patient, implanted with a pacemaker, was transported to the hospital due to ventricular fibrillation.The pacemaker was interrogated on (b)(6) 2016 at 08:54 and again at 14:48.During interrogation at 14:48, the programming head was reportedly nearly falling down, and was repositioned.Then, the programmer screen reportedly became black and the programmer shut down.The programmer was rebooted, and interrogation of the pacemaker was performed successfully.

Manufacturer Narrative

Please refer to the attached preliminary analysis report.

Event Description

During the night between (b)(6) 2016, the patient, implanted with a pacemaker, was transported to the hospital due to ventricular fibrillation.The pacemaker was interrogated on (b)(6) 2016 at 08:54 and again at 14:48.During interrogation at 14:48, the programming head was reportedly nearly falling down, and was repositioned.Then, the programmer screen reportedly became black and the programmer shut down.The programmer was rebooted, and interrogation of the pacemaker was performed successfully.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

During the night between (b)(6) 2016, the patient, implanted with a pacemaker, was transported to the hospital due to ventricular fibrillation.The pacemaker was interrogated on (b)(6) 2016 at 08:54 and again at 14:48.During interrogation at 14:48, the programming head was reportedly nearly falling down, and was repositioned.Then, the programmer screen reportedly became black and the programmer shut down.The programmer was rebooted, and interrogation of the pacemaker was performed successfully.

• 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: 5572884
• MDR Text Key: 43044947
• Report Number: 1000165971-2016-00212
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/22/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/18/2016; 08/22/2016
• 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