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

Model Number	PARADYM RF DR 9550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, an infection relative to the subject device occurred.The device was explanted on (b)(6) 2020.

• Brand Name: PARADYM RF
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 11295696
• Report Number: 1000165971-2021-00264
• Device Sequence Number: 14692316
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)150407(17)160507
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 05/07/2016
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: S0075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/08/2021
• 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