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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, atrial and ventricular lead impedance measurements were out of range (high) for the period: (b)(6) 2018 to (b)(6) 2018 (33 days).Patient states that was not in contact with any emi sources and did not undergo to any medical procedures.Other lead impedance measurements were in normal range.
Event or Problem Description
Reportedly, atrial and ventricular lead impedance measurements were out of range (high) for the period: 5 jan 2018 to 7 feb 2018 (33 days).Patient states that was not in contact with any emi sources and did not undergo to any medical procedures.Other lead impedance measurements were in normal range.

• 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: 7629454
• Report Number: 1000165971-2018-00587
• Device Sequence Number: 1898788
• Product Code: DXY
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)120611(17)140111
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 01/11/2014
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2627
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2018
• Event Location: Home
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1