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 Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The country of the event is (b)(6).Due to technical limitations, this country cannot be entered in this field.
Event or Problem Description
Reportedly, on (b)(6) 2020, the patient went to the hospital following shocks.A magnet has been applied on the device for a week; however, when removing the magnet, the patient received shocks again.A lead fracture is suspected.Preliminary analysis confirmed the presence of ventricular noise oversensing episodes leading to inappropriate shocks deliveries.This noise oversensing most probably resulted from a ventricular lead issue and/or connection issue; however, none of them could be confirmed with certainty.
Event or Problem Description
Reportedly, on (b)(6) 2020, the patient went to the hospital following shocks.A magnet has been applied on the device for a week; however, when removing the magnet, the patient received shocks again.A lead fracture is suspected.Preliminary analysis confirmed the presence of ventricular noise oversensing episodes leading to inappropriate shocks deliveries.This noise oversensing most probably resulted from a ventricular lead issue and/or connection issue; however, none of them could be confirmed with certainty.
Additional Manufacturer Narrative
E1 field: the country of the event is peru.Due to technical limitations, this country cannot be entered in this field.

• 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: 9793477
• Report Number: 1000165971-2020-00283
• Device Sequence Number: 14025494
• Product Code: NIK
• UDI-Device Identifier: 08031527015538
• UDI-Public: (01)08031527015538(11)180112(17)200712
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 07/12/2020
• Device Model Number: PLATINIUM CRT-D 1711
• Device Catalogue Number: PLATINIUM CRT-D 1711
• Device Lot Number: S0297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: Hospitalization