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

Model Number REPLY SR

Device Problems Failure to Capture (1081); Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)

Patient Problem Syncope (1610)

Event Date 10/09/2020

Event Type  Injury  

Event Description

Reportedly, the patient was admitted to the hospital on (b)(6) 2020 due to a syncope.Upon device interrogation, loss of capture was observed in several episodes recorded in the device memory.The physician decided to program the automatic ventricular threshold feature.Absence of ventricular capture with an output at 4 v was observed during the calibration phase, although the ventricular capture threshold was measured at 0.75 v ¿ 1 v/0.5 ms manually.It was reported that a recent fall could have damaged the ventricular lead, though it could not be confirmed on the x-ray or by reviewing the lead impedance curve.Additionally, loss of capture could not be reproduced during the follow-up.It was only observed in specific postural conditions.It was decided to replace the ventricular lead.Preliminary analysis revealed that the ventricular auto-threshold failed because calibration phase criteria were not met.

Event Description

Reportedly, the patient was admitted to the hospital on (b)(6) 2020 due to a syncope.Upon device interrogation, loss of capture was observed in several episodes recorded in the device memory.The physician decided to program the automatic ventricular threshold feature.Absence of ventricular capture with an output at 4 v was observed during the calibration phase, although the ventricular capture threshold was measured at 0.75 v ¿ 1 v/0.5 ms manually.It was reported that a recent fall could have damaged the ventricular lead, though it could not be confirmed on the x-ray or by reviewing the lead impedance curve.Additionally, loss of capture could not be reproduced during the follow-up.It was only observed in specific postural conditions.It was decided to replace the ventricular lead.Preliminary analysis revealed that the ventricular auto-threshold failed because calibration phase criteria were not met.

• 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: 10852990
• MDR Text Key: 216673965
• Report Number: 1000165971-2020-00739
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527012247
• UDI-Public: (01)08031527012247(11)161005(17)180108
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 01/08/2018
• Device Model Number: REPLY SR
• Device Catalogue Number: REPLY SR
• Device Lot Number: S0223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2020
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention