MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM VR 1210

Device Problems Telemetry Discrepancy (1629); Reset Problem (3019)

Patient Problem No Information (3190)

Event Date 07/21/2016

Event Type  malfunction  

Event Description

During the implantation procedure of the subject icd, normal behavior of rf telemetry was observed until the icd was connected to the leads.Reportedly, when performing tests, the rf head had one blinking light, and the signal could not be improved even when changing the position of the rf head.The user switched to inductive telemetry (with sterile protection), and several attempts to restore communication were performed, including shutting down the programmer.It was eventually possible to interrogate the icd in inductive telemetry.Upon interrogation, the icd was found in standby mode and re-initialization was performed.Then the icd was programmed and all tests were normally performed.

Manufacturer Narrative

In depth investigations revealed that an electrostatic discharge (esd) could have occurred at implantation, triggering the device reset.However, the power on reset hypothesis could not be excluded based on available data.Therefore, investigations are still ongoing.Analysis confirmed that the loss of rf communication was due to the reset, and the loss of inductive communication was most probably due to a wrong positioning of the telemetry head.The device was properly re-initialized after the reset.

Event Description

During the implantation procedure of the subject icd, normal behavior of rf telemetry was observed until the icd was connected to the leads.Reportedly, when performing tests, the rf head had one blinking light, and the signal could not be improved even when changing the position of the rf head.The user switched to inductive telemetry (with sterile protection), and several attempts to restore communication were performed, including shutting down the programmer.It was eventually possible to interrogate the icd in inductive telemetry.Upon interrogation, the icd was found in standby mode and re-initialization was performed.Then the icd was programmed and all tests were normally performed.

Manufacturer Narrative

In-depth investigations confirmed that the reset of the icd was most likely attributable to an esd (electrostatic discharge) that could have occurred at implantation.

Event Description

During the implantation procedure of the subject icd, normal behavior of rf telemetry was observed until the icd was connected to the leads.Reportedly, when performing tests, the rf head had one blinking light, and the signal could not be improved even when changing the position of the rf head.The user switched to inductive telemetry (with sterile protection), and several attempts to restore communication were performed, including shutting down the programmer.It was eventually possible to interrogate the icd in inductive telemetry.Upon interrogation, the icd was found in standby mode and re-initialization was performed.Then the icd was programmed and all tests were normally performed.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

During the implantation procedure of the subject icd, normal behavior of rf telemetry was observed until the icd was connected to the leads.Reportedly, when performing tests, the rf head had one blinking light, and the signal could not be improved even when changing the position of the rf head.The user switched to inductive telemetry (with sterile protection), and several attempts to restore communication were performed, including shutting down the programmer.It was eventually possible to interrogate the icd in inductive telemetry.Upon interrogation, the icd was found in standby mode and re-initialization was performed.Then the icd was programmed and all tests were normally performed.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 5878978
• MDR Text Key: 52727004
• Report Number: 1000165971-2016-00488
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2017
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/21/2016
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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