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

Model Number REPLY DR

Device Problem Over-Sensing (1438)

Patient Problems Fainting (1847); Dizziness (2194)

Event Date 09/27/2019

Event Type  Injury  

Event Description

Reportedly, the patient, who is pacemaker-dependent, complained about fainting and dizziness since the follow-up performed on (b)(6) 2019.Review of patient files retrieved during the follow-ups performed on (b)(6) 2019, (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019 revealed noise on both atrial and ventricular channels.No provocative maneuvers were performed during the follow-up dated (b)(6) 2019, as no doctor was present.Besides, the programmed settings remained unchanged: pacing mode set in safer with a basic rate at 60 min-1, atrial pacing output at 2.0 v/ 0.35ms and ventricular pacing output at 2.5 v/ 0.35 ms.During the follow-up performed on (b)(6) 2019, the pacing mode was re-programmed to doo.During the follow-up dated (b)(6) 2019, the ventricular pacing output was re-programmed to 4.0 v/0.35 ms.The next follow-up was performed on (b)(6) 2020.Preliminary analysis confirmed simultaneous noise oversensing on both channels.The origin of these non-physiological signals is unknown.It could be located at lead(s) level, connection(s) level or pacemaker level; none of them can be confirmed with available data.

Event Description

Reportedly, the patient, who is pacemaker-dependent, complained about fainting and dizziness since the follow-up performed on (b)(6)2019.Review of patient files retrieved during the follow-ups performed on (b)(6)2019 27 (b)(6)2019 ,(b)(6)2019 and (b)(6)2019 revealed noise on both atrial and ventricular channels.No provocative maneuvers were performed during the follow-up dated (b)(6)2019 , as no doctor was present.Besides, the programmed settings remained unchanged: pacing mode set in safer with a basic rate at 60 min-1, atrial pacing output at 2.0 v/ 0.35ms and ventricular pacing output at 2.5 v/ 0.35 ms.During the follow-up performed on 27 (b)(6)2019 , the pacing mode was re-programmed to doo.During the follow-up dated (b)(6)2019 , the ventricular pacing output was re-programmed to 4.0 v/0.35 ms.The next follow-up was performed on 23 january 2020.Preliminary analysis confirmed simultaneous noise oversensing on both channels.The origin of these non-physiological signals is unknown.It could be located at lead(s) level, connection(s) level or pacemaker level; none of them can be confirmed with available data.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: REPLY
• Type of Device: 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: 9659168
• MDR Text Key: 183909379
• Report Number: 1000165971-2020-00245
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2015
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2777
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2020
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention