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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject device was explanted due to infection on (b)(6) 2017.An investigation is required.
Event or Problem Description
It was reported that the subject device was explanted due to infection on (b)(6) 2017.An investigation is required.

• 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: 6766580
• Report Number: 1000165971-2017-00625
• Device Sequence Number: 19224030
• Product Code: NIK
• UDI-Device Identifier: 08031527015484
• UDI-Public: (01)08031527015484(11)160919(17)180419
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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: 04/19/2018
• Device Model Number: PLATINIUM CRT-D 1741
• Device Catalogue Number: PLATINIUM CRT-D 1741
• Device Lot Number: S0218
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/08/2017
• 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