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 Problems High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/03/2019

Event Type  Injury  

Event Description

Reportedly, several warnings were displayed on the overview screen during a follow-up performed on 03 december 2019.Moreover, noise oversensing was observed on the atrial and ventricular channels in the recorded episodes.The associated rv lead was implanted following the re-intervention performed on (b)(6) 2018 to replace the previously implanted rv lead.Preliminary analysis results showed non-physiological signals in the atrial and ventricular channels, leading to the reported noise oversensing in both channels and the delivery of two inappropriate shocks.The observed noise most probably resulted from leads issues and/or leads/crt-d connection issues.

Event Description

Reportedly, several warnings were displayed on the overview screen during a follow-up performed on (b)(6)2019.Moreover, noise oversensing was observed on the atrial and ventricular channels in the recorded episodes.The associated rv lead was implanted following the re-intervention performed on (b)(6)2018 to replace the previously implanted rv lead.Preliminary analysis results showed non-physiological signals in the atrial and ventricular channels, leading to the reported noise oversensing in both channels and the delivery of two inappropriate shocks.The observed noise most probably resulted from leads issues and/or leads/crt-d connection issues.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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
• MDR Report Key: 9523167
• MDR Text Key: 174411737
• Report Number: 1000165971-2019-00743
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527015538
• UDI-Public: (01)08031527015538(11)160627(17)180127
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2018
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: PLATINIUM CRT-D 1711
• Device Lot Number: S0194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention