MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D044

Device Problems Failure to Capture (1081); High impedance (1291); Unexpected Therapeutic Results (1631); High Capture Threshold (3266)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) and associated right ventricular (rv) lead exhibited a gradual increase in pacing threshold measurements.Sensing, and pacing and shocking impedance measurements were within normal limits.There were no stored episodes showing noise, and noise was not produced with provocative maneuvers.A request was made for technical services to review the available device data in the remote monitoring system.Technical services reviewed the available data and noted no evidence suggesting a lead integrity issue.However, some abnormal pacing where the pacing was not effective was observed.Technical services recommended x-rays to evaluate lead placement and further testing the stability of lead measurements when the patient is changing postures.It was noted that patient is rv paced 0%, so these observations were intermittent.No adverse patient effects were reported.The device and lead remain implanted and in service.Additional infromation was received.One year later, the local sales representative reported the icd was planned to be replaced as it had less than three months until elective replacement indicator (eri) battery status.The physician would decide then if the rv lead would also be changed.Technical services observed high pacing thresholds, with the output programmed to 7.5v, with evidence of loss of capture.Also, the pacing impedance measurements had increased from 550 ohms to 660 ohms.The local sales representative confirmed the icd was explanted and replaced and will not be returned for analysis.The rv lead was tested at the device change out procedure.Defibrillation threshold (dft) testing was performed with successful vf conversion at 31 joules, with a normal shock impedance of 85 ohms.Sensing, pacing impedance and shock impedance measurements were stable.Pacing threshold measurements were intermittent at 7v @ 2ms; however, the physician elected to keep the rv lead and it remains in use with the new device.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: AUTOGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19070077
• MDR Text Key: 339886176
• Report Number: 2124215-2024-21425
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Expiration Date: 12/12/2018
• Device Model Number: D044
• Device Catalogue Number: D044
• Device Lot Number: 212436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1