MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number	PLATINIUM VR 1210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, on (b)(6) 2019, the subject icd was explanted due to a pocket infection.Preliminary analysis revealed that the subject device has been sterilized and released according to all applicable procedures.
Additional Manufacturer Narrative
D3 (email address) corrected.F14 (email address) corrected.G1-2 (first name, last name, email address, phone number) corrected.Please refer to the attached analysis report.
Event or Problem Description
Reportedly, on (b)(6)2019 , the subject icd was explanted due to a pocket infection.Preliminary analysis revealed that the subject device has been sterilized and released according to all applicable procedures.

• Brand Name: PLATINIUM
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 8874326
• Report Number: 1000165971-2019-00465
• Device Sequence Number: 16832854
• Product Code: MRM
• UDI-Device Identifier: 08031527015514
• UDI-Public: (01)08031527015514(11)171004(17)190504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 05/04/2019
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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