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 1741
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A "generator failure" was reported to have occurred.This device is under the advisory of the field safety notice of july 2018 on platinum devices.
Event or Problem Description
A "generator failure" was reported to have occurred.This device is under the advisory of the field safety notice of july 2018 on platinum devices.
Additional Manufacturer Narrative
The preliminary analysis of the returned device did not reveal any irregularities.
Additional Manufacturer Narrative
Please refer to the attached investigation report.
Event or Problem Description
A "generator failure" was reported to have occurred.This device is under the advisory of the field safety notice of(b)(6)2018 on platinum devices.Capture failure on the left ventricular channel was also reported.

• 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: 9296622
• Report Number: 1000165971-2019-00626
• Device Sequence Number: 560167
• Product Code: NIK
• UDI-Device Identifier: 08031527015484
• UDI-Public: (01)08031527015484(11)160630(17)180130
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2020

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: 01/30/2018
• Device Model Number: PLATINIUM CRT-D 1741
• Device Catalogue Number: PLATINIUM CRT-D 1741
• Device Lot Number: S0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 01/07/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2825-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention