MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Connection Problem (2900); High Capture Threshold (3266)

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

Event Date 10/13/2021

Event Type  malfunction  

Event Description

It was reported that a literature review, titled, shekar, vijay, et al.(2022)."high rate episodes in a dual chamber pacemaker: what is the mechanism?".Pacing clin electrophysiol.2022;45:238-240.Https://doi.Org/10.1111/pace.14430.Reviewed a patient who underwent a dual chamber pacemaker implantation (boston scientific, advantio mri conditional) for symptomatic complete atrioventricular block at an outside institution.A month after implant, the patient was found to have high atrial and ventricular rate episodes during interrogation and referred for further evaluation.On device interrogation, it was found to be in dddr mode, and high frequency low amplitude noise was detected on both atrial and ventricular channels.The atrial high rate episodes triggered inappropriate mode switch.Device diagnostics also revealed high pacing impedance in the atrial and ventricular leads.The atrial lead impedance had increased abruptly (>2000 ohms) and remained elevated.Atrial pacing thresholds were found to be high (2.6 v @0.40 ms).The ventricular lead had an intermittent, increase in impedance (>2000 ohms), while the ventricular threshold was normal.Device diagnostics also revealed automatic switch of minute ventilation (mv) sensing from atrial to ventricular channel.Atrial pacing was programmed to unipolar configuration, and minute ventilation (mv) sensor was switched off, which resulted in elimination of noise and normalization of pacing impedance.Fluoroscopy revealed the incomplete insertion of both atrial and ventricular leads in the header.Atrial lead insertion was more incomplete compared to ventricular lead.It was noted that this explained the impedance trends of both the leads.The noise characteristics were consistent with electromagnetic interference (emi) from unknown source and was suspected to be due to mv oversensing.The device remains implanted.No adverse patient effects were reported.

Manufacturer Narrative

This investigation is complete.Should additional information become available this investigation will be updated.

• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15626259
• MDR Text Key: 307089975
• Report Number: 2124215-2022-42090
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• 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 Age: 60 YR
• Patient Sex: Male