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

Model Number	REPLY SR
Medical Device Problem Codes	Failure to Capture (1081); Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: 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
• Report Number: 1000165971-2020-00739
• Device Sequence Number: 13613464
• Product Code: NVZ
• UDI-Device Identifier: 08031527012247
• UDI-Public: (01)08031527012247(11)161005(17)180108
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention