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	Output Problem (3005)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, the subject pacemaker was returned from the customer, who did not want to keep it in consignment because it was in unipolar configuration.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, the subject pacemaker was returned from the customer, who did not want to keep it in consignment because it was in unipolar configuration.

• 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: 7766713
• Report Number: 1000165971-2018-00740
• Device Sequence Number: 11281836
• Product Code: NVZ
• UDI-Device Identifier: 08031527012247
• UDI-Public: (01)08031527012247(11)170613(17)190113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: 01/13/2019
• Device Model Number: REPLY SR
• Device Catalogue Number: REPLY SR
• Device Lot Number: S0268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1