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

Model Number REPLY D

Device Problems Failure to Capture (1081); Over-Sensing (1438); Unstable Capture Threshold (3269)

Patient Problem Fainting (1847)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the patient was hospitalized because he fainted.Upon pacemaker interrogation, the physician observed several episodes showing noise oversensing and intermittent loss of capture was noted on an ecg.Tests were performed and the threshold was measured at 1 ¿ 1.25 v / 0.6 ms.The ventricular waves were measured at 5 mv.Preliminary analysis revealed that the ventricular noise oversensing and loss of ventricular capture most probably resulted from a ventricular lead issue and/or a lead-pacemaker connection issue at ventricular level.

Event Description

Reportedly, the patient was hospitalized because he fainted.Upon pacemaker interrogation, the physician observed several episodes showing noise oversensing and intermittent loss of capture was noted on an ecg.Tests were performed and the threshold was measured at 1 ¿ 1.25 v / 0.6 ms.The ventricular waves were measured at 5 mv.Preliminary analysis revealed that the ventricular noise oversensing and loss of ventricular capture most probably resulted from a ventricular lead issue and/or a lead-pacemaker connection issue at ventricular level.

• 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: 8995095
• MDR Text Key: 160162744
• Report Number: 1000165971-2019-00537
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527008998
• UDI-Public: (01)08031527008998(11)190325(17)201025
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: REPLY D
• Device Catalogue Number: REPLY D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2019
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1