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	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the defibrillation system was explanted due to infection.The subject device will be returned for analysis.An investigation is required.Preliminary analysis showed that the device has been sterilized and released according to all applicable procedures.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reportedly, the defibrillation system was explanted due to infection.The subject device will be returned for analysis.An investigation is required.Preliminary analysis showed that the device has been sterilized and released according to all applicable procedures.

• Brand Name: PARADYM RF
• 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: 6571898
• Report Number: 1000165971-2017-00400
• Device Sequence Number: 507767
• Product Code: NIK
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)140414(17)150514
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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: 05/14/2015
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2815
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 09/15/2017
• 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