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

Model Number	REPLY SR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that implantation date has been selected as the expiration date ((b)(6) 2018) for system limitation.
Event or Problem Description
Reportedly, the subject device was implanted on (b)(6) 2018 after it passed the use-by-date ((b)(6) 2018).Preliminary analysis did not reveal any technical and safety issue.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, the subject device was implanted on (b)(6) 2018 after it passed the use-by-date (b)(6) 2018).Preliminary analysis did not reveal any technical and safety issue.

• 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: 7762174
• Report Number: 1000165971-2018-00731
• Device Sequence Number: 1445930
• Product Code: DXY
• UDI-Device Identifier: 08031527012247
• UDI-Public: (01)08031527012247(11)170110(17)180517
• 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: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: REPLY SR
• Device Catalogue Number: REPLY SR
• Device Lot Number: S0241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1