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
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Please refer to the attached analysis report.

• Brand Name: PLATINIUM
• Common Device Name: 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
• Report Number: 1000165971-2019-00743
• Device Sequence Number: 2694920
• Product Code: NIK
• UDI-Device Identifier: 08031527015538
• UDI-Public: (01)08031527015538(11)160627(17)180127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention