MAUDE Adverse Event Report: MICROPORT CRM S.R.L. VEGA; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number VEGA R45

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

Reportedly, atrial lead noise in the vega r45 lead s/n: (b)(6) was observed on the egm a recorded when the device was interrogated on (b)(6) 2023.The physician decided to replace the pacemaker (not the lead) because the pacing threshold and resistance values were within normal limits and the noise was only recorded in the morning, it was determined that external electromagnetic interference was likely the source of the noise recorded, and reintervention to replace the pacemaker (not the lead) was performed as planned on (b)(6) 2023.According to the physician, if it was electromagnetic interference in daily life, he thought that noise would not be observed during the hospitalization period after the pacemaker replacement.However, upon interrogation on (b)(6) 2023 atrial lead noise was observed again as an atrial arrhythmia episode.

Event Description

Reportedly, atrial lead noise in the vega r45 lead (s/n: (b)(6)) was observed on the egm a recorded when the device was interrogated on (b)(6) 2023.The physician decided to replace the pacemaker (not the lead) because the pacing threshold and resistance values were within normal limits and the noise was only recorded in the morning, it was determined that external electromagnetic interference was likely the source of the noise recorded, and reintervention to replace the pacemaker (not the lead) was performed as planned on (b)(6) 2023.According to the physician, if it was electromagnetic interference in daily life, he thought that noise would not be observed during the hospitalization period after the pacemaker replacement.However, upon interrogation on (b)(6) 2023, atrial lead noise was observed again as an atrial arrhythmia episode.

Manufacturer Narrative

H6 evaluation code: health effect impact.No health consequence or impact.Summary of the investigation: review of provided data confirmed the reported atrial oversensing and the episodes recorded in the kora dr and eno dr devices memories showed oversensing and non-physiological signals (noise/artifacts) on atrial channel.The origin of these simultaneous non-physiological atrial signals and noise is unknown.As the lead remains implanted, it was not returned for investigation.Therefore, the exact root cause could not be determined.A careful monitoring of the atrial lead integrity should be performed to ensure the adequate sensing and pacing functionality.This case is retained and utilized for trending purposes.For more details please refer to the attached report analysis.

• Brand Name: VEGA
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: 18482353
• MDR Text Key: 333093969
• Report Number: 1000165971-2024-00041
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VEGA R45
• Device Catalogue Number: VEGA R45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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