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

Model Number REPLY DR

Device Problem Intermittent Capture (1080)

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

Event Date 01/05/2021

Event Type  Injury  

Event Description

Reportedly, during an interrogation after a visit to the emergency room, vrvn markers were observed on the egm.In a holter that was performed, ventricular capture failure was suspected.On (b)(6) 2021, in a follow-up consultation, vrvn markers were again observed at the beginning of the consultation, however the physician could not reproduce these markers during the consultation.On the same day, another holter was performed and ventricular capture failure was suspected.The physician would like to know if the vrvn markers are related to the capture failures that were observed on the holter.Preliminary analysis revealed that a ventricular lead issue and/or a lead-pacemaker connection issue at ventricular level is suspected.

Event Description

Reportedly, during an interrogation after a visit to the emergency room, vrvn markers were observed on the egm.In a holter that was performed, ventricular capture failure was suspected.On (b)(6) 2021, in a follow-up consultation, vrvn markers were again observed at the beginning of the consultation, however the physician could not reproduce these markers during the consultation.On the same day, another holter was performed and ventricular capture failure was suspected.The physician would like to know if the vrvn markers are related to the capture failures that were observed on the holter.Preliminary analysis revealed that a ventricular lead issue and/or a lead-pacemaker connection issue at ventricular level is suspected.

Manufacturer Narrative

Please refer to the attached analysis report.D3 (email address) and g1 (first name, last name, email address, telephone number) corrected.

• 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: 11274033
• MDR Text Key: 230101559
• Report Number: 1000165971-2021-00259
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527008882
• UDI-Public: (01)08031527008882(11)180418(17)191118
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: 11/18/2019
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention