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

Model Number REPLY DR

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Ventricular Tachycardia (2132)

Event Date 10/22/2020

Event Type  Injury  

Event Description

Reportedly, on (b)(6) 2020, during the replacement of the subject pacemaker due to battery depletion, the device was programmed in vvi mode and the ventricular lead was set to unipolar sensing and pacing.During this intervention, electrocautery was used, and then ventricular pacing and a high rate ventricular tachycardia were observed.It was confirmed that smoothing was set to on.As it was unsure if the tachycardia resulted from inappropriate pacing of the device, it was decided to program it in ooo mode to finish the intervention.

Event Description

Reportedly, on (b)(6) 2020, during the replacement of the subject pacemaker due to battery depletion, the device was programmed in vvi mode and the ventricular lead was set to unipolar sensing and pacing.During this intervention, electrocautery was used, and then ventricular pacing and a high rate ventricular tachycardia were observed.It was confirmed that smoothing was set to on.As it was unsure if the tachycardia resulted from inappropriate pacing of the device, it was decided to program it in ooo mode to finish the intervention.

Manufacturer Narrative

Electrical characteristics of the returned unit were within specifications.It is suspected that the pacing at high rate resulted from an interaction at the level of the smoothing algorithm.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, on (b)(6) 2020, during the replacement of the subject pacemaker due to battery depletion, the device was programmed in vvi mode and the ventricular lead was set to unipolar sensing and pacing.During this intervention, electrocautery was used, and then ventricular pacing and a high rate ventricular tachycardia were observed.It was confirmed that smoothing was set to on.As it was unsure if the tachycardia resulted from inappropriate pacing of the device, it was decided to program it in ooo mode to finish the intervention.

• 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: 10835454
• MDR Text Key: 216095420
• Report Number: 1000165971-2020-00718
• Device Sequence Number: 1
• Product Code: NVZ
• 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,Followup
• Report Date: 03/26/2021

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: 04/18/2011
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 02/02/2021; 03/02/2021
• Supplement Dates FDA Received: 02/25/2021; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention