MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	REPLY DR
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reportedly suffered from a sepsis (presence of (b)(6)) which led to the explantation of the subject device on (b)(6) 2017.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2017 it was reported that the device was explanted on (b)(6) 2017 for an upgrade implantation of a cardiac defibrillator.Sepsis was not the reason of the explantation.Device symptoms is corrected.
Event or Problem Description
The patient reportedly suffered from a sepsis (presence of staphylococcus aureaus) which led to the explantation of the subject device on (b)(6) 2017.
Additional Manufacturer Narrative
Please refer to the attached report.
Event or Problem Description
The patient reportedly suffered from a sepsis (presence of staphylococcus aureaus) which led to the explantation of the subject device on (b)(6) 2017.

• Brand Name: REPLY
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 6763064
• Report Number: 1000165971-2017-00620
• Device Sequence Number: 13677558
• Product Code: NVZ
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)120328(17)131028
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2017

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: 10/28/2013
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/11/2017; 11/14/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/11/2017; 12/13/2017
• 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