MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY VDR

Device Problems Premature Discharge of Battery (1057); Over-Sensing (1438)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The pacing system was implanted on (b)(6) 2012.Reportedly, during a follow-up performed on (b)(6) 2020, the estimated residual longevity was displaying 9 months, though it was 3 years on (b)(6) 2019, with a battery impedance measured at 1.61 kohms.Preliminary analysis revealed that normal battery depletion occurred according to hrs guidelines.Almost all the episodes recorded in the device memory since (b)(6) 2019 showed non-physiological signals on the atrial and ventricular channels, leading to ventricular noise oversensing.The observed noise most probably resulted from a lead issue.

Event Description

The pacing system was implanted on (b)(6) 2012.Reportedly, during a follow-up performed on (b)(6) 2020, the estimated residual longevity was displaying 9 months, though it was 3 years on (b)(6) 2019, with a battery impedance measured at 1.61 kohms.Preliminary analysis revealed that normal battery depletion occurred according to hrs guidelines.Almost all the episodes recorded in the device memory since (b)(6) 2019 showed non-physiological signals on the atrial and ventricular channels, leading to ventricular noise oversensing.The observed noise most probably resulted from a lead issue.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11047130
• MDR Text Key: 223400534
• Report Number: 1000165971-2020-00833
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 03/31/2021

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: 02/11/2013
• Device Model Number: REPLY VDR
• Device Catalogue Number: REPLY VDR
• Device Lot Number: 2586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1