MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number PLATINIUM CRT-D 1711

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Ventricular Tachycardia (2132)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2016, the patient was in the surgery room for ablation of vt.The physician interrogated the device to switch off the tachy therapies with an upgraded programmer (2.54 version).The platinum firmware was then installed by inductive telemetry.When the upgrading process finished, the physician saw a non sustained vt in main screen.The device memory was then checked but no episode was recorded associated to the vt.Instead of this one, there were several svt episodes dated (b)(6) 2007.The physician asks for an analysis about this unexpected behavior.Preliminary analysis confirmed the reported behavior.The issue was most probably due to telemetry errors.No software anomaly was identified.

Event Description

Reportedly, on (b)(6) 2016, the patient was in the surgery room for ablation of vt.The physician interrogated the device to switch off the tachy therapies with an upgraded programmer (2.54 version).The platinum firmware was then installed by inductive telemetry.When the upgrading process finished, the physician saw a non sustained vt in main screen.The device memory was then checked but no episode was recorded associated to the vt.Instead of this one, there were several svt episodes dated (b)(6) 2007.The physician asks for an analysis about this unexpected behavior.Preliminary analysis confirmed the reported behavior.The issue was most probably due to telemetry errors.No software anomaly was identified.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• 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): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 6116277
• MDR Text Key: 60629928
• Report Number: 1000165971-2016-00743
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060027
• 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
• Report Date: 10/25/2016

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 Expiration Date: 06/27/2017
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: PLATINIUM CRT-D 1711
• Device Lot Number: S0132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/25/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1