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

Model Number	REPLY DR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the subject pacemaker was explanted due to infection.Preliminary analysis revealed that the subject device has been sterilized and released according to all applicable procedures.
Additional Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200526 - file-2020-00986 - analysis_and_closure_report_resp-2020-00618.Pdf].
Event or Problem Description
Reportedly, the subject pacemaker was explanted due to infection.Preliminary analysis revealed that the subject device has been sterilized and released according to all applicable procedures.

• 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: 10008571
• Report Number: 1000165971-2020-00381
• Device Sequence Number: 2740183
• Product Code: DXY
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)151014(17)170514
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 05/14/2017
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/26/2020
• 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