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	Over-Sensing (1438); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, episodes showing ventricular oversensing were observed in the device memories during a routine follow-up performed on (b)(6) 2018.In one episode, a shock was triggered but could not be delivered due to overload detection.Preliminary analysis confirmed the reported issue and showed that it was most probably due to a defibrillation lead issue.Based on available data, no issue is suspected on the icd.Recommendations to replace the defibrillation lead were sent on (b)(6) 2018.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, episodes showing ventricular oversensing were observed in the device memories during a routine follow-up performed on (b)(6) 2018.In one episode, a shock was triggered but could not be delivered due to overload detection.Preliminary analysis confirmed the reported issue and showed that it was most probably due to a defibrillation lead issue.Based on available data, no issue is suspected on the icd.Recommendations to replace the defibrillation lead were sent on (b)(6) 2018.
Additional Manufacturer Narrative
The associated ventricular lead was replaced in december 2018.
Event or Problem Description
Reportedly, episodes showing ventricular oversensing were observed in the device memories during a routine follow-up performed on (b)(6)2018.In one episode, a shock was triggered but could not be delivered due to overload detection.Preliminary analysis confirmed the reported issue and showed that it was most probably due to a defibrillation lead issue.Based on available data, no issue is suspected on the icd.Recommendations to replace the defibrillation lead were sent on (b)(6)2018.

• 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: 7685877
• Report Number: 1000165971-2018-00642
• Device Sequence Number: 16332825
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2019

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: 06/18/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 03/26/2019
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/17/2018; 03/28/2019
• 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