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	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, battery depletion occurred earlier than expected.The device should be returned for analysis.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.
Additional Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200415 - file-2019-04150 - analysis_and_closure_report_resp-2020-00387.Pdf].
Event or Problem Description
Reportedly, battery depletion occurred earlier than expected.The device should be returned for analysis.Preliminary analysis results showed that based on available data, normal battery depletion occurred based on hrs guidelines.

• 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: 9516069
• Report Number: 1000165971-2019-00739
• Device Sequence Number: 3462234
• Product Code: NVZ
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)161011(17)171205
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 12/05/2017
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2019
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 04/16/2020
• 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