MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number REPLY 200 DR

Device Problems Premature Discharge of Battery (1057); Premature Elective Replacement Indicator (1483)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 10/05/2022

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.Preliminary analysis of the patient files provided did not reveal any anomaly.Patient files analysis revealed that the device has been explanted before the recommended replacement time on (b)(6)2022 with a battery impedance of 3.08k.The time to rrt was indicated at 10 months minimum.Therefore, for the following analysis, it is considered the rrt would have been reached on (b)(6)2022(minimum), and the device explantation would have taken place at this time.Based on available data, the expected overall longevity is estimated at ¿ 125 months (10 years 5 months).The implantation duration would have been 99.5 months, which is higher than (b)(4) of the estimated overall longevity ((b)(4) of 125 months = 94 months).Based on hrs guidelines, normal battery depletion occurred.

Event Description

Reportedly, on (b)(6)2022, the reply 200 dr was replaced due to battery depletion.The battery longevity was more than 8 years at the time of the 2017 f/u check, but the battery longevity was more than 5 years at the time of the 2018 f/u check, which was shortened by 3 years in 1 year.

Event Description

Reportedly, on (b)(6) 2022, the reply 200 dr was replaced due to battery depletion.The battery longevity was more than 8 years at the time of the 2017 f/u check, but the battery longevity was more than 5 years at the time of the 2018 f/u check, which was shortened by 3 years in 1 year.

Manufacturer Narrative

Correction of the "date of this report " of the follow-up1, to on (b)(6) 2022.Upon reception, the returned device was interrogated and found operating in safer mode, 40min-1, ventricular channel was with 2.5v amplitude and 0.35ms pacing pulse width; pacing pulses were delivered appropriately in a and v channels.Normal sensitivity was measured also in both channels.No overconsumption was observed during consumption measurements by telemetry.The device was then submitted to the standard electrical manufacturing test: no significant difference was observed when comparing the results with those obtained during the manufacturing cycle (at the time the device was manufactured).H3 other text: device returned, but evaluation not finished yet.

Manufacturer Narrative

Upon reception, the returned device was interrogated and found operating in safer mode, 40min-1, ventricular channel was with 2.5v amplitude and 0.35ms pacing pulse width; pacing pulses were delivered appropriately in a and v channels.Normal sensitivity was measured also in both channels.No overconsumption was observed during consumption measurements by telemetry.The device was then submitted to the standard electrical manufacturing test: no significant difference was observed when comparing the results with those obtained during the manufacturing cycle (at the time the device was manufactured).H3 other text : device returned, but evaluation not finished yet.

Event Description

Reportedly, on (b)(6) 2022, the reply 200 dr was replaced due to battery depletion.The battery longevity was more than 8 years at the time of the 2017 f/u check, but the battery longevity was more than 5 years at the time of the 2018 f/u check, which was shortened by 3 years in 1 year.

Event Description

Reportedly, on (b)(6) 2022, the reply 200 dr was replaced due to battery depletion.The battery longevity was more than 8 years at the time of the 2017 f/u check, but the battery longevity was more than 5 years at the time of the 2018 f/u check, which was shortened by 3 years in 1 year.

Event Description

Reportedly, on (b)(6) 2022, the reply 200 dr was replaced due to battery depletion.The battery longevity was more than 8 years at the time of the 2017 f/u check, but the battery longevity was more than 5 years at the time of the 2018 f/u check, which was shortened by 3 years in 1 year.

Manufacturer Narrative

Correction: the analysis report was missing in the previous mdr (dated of 02 feb 2023).

• Brand Name: REPLY
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 15649829
• MDR Text Key: 304965084
• Report Number: 1000165971-2022-00461
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REPLY 200 DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic