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

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Low impedance (2285); High Capture Threshold (3266)

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

Event Date 12/29/2023

Event Type  malfunction  

Event Description

It was reported that an alert had been generated for this system for out-of-range intrinsic amplitude measurements on the right ventricular (rv) channel.Stored electrograms (egms) showed two episodes of noise and oversensing which resulted in pacing inhibition.Ventricular threshold trends showed increased threshold measurements and decreased pacing impedance measurements over the past two months.Additionally, farfield r wave oversensing (ffrwos) caused false atrial tachycardia response (atr) storage.A boston scientific technical services consultant recommended in office assessment of the rv lead.The model, serial and manufacturer of the rv lead is unknown.No adverse patient effects were reported.Additional information was received confirming the rv lead was manufactured by boston scientific corporation and was implanted in october 2012.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that an alert had been generated for this system for out-of-range intrinsic amplitude measurements on the right ventricular (rv) channel.Stored electrograms (egms) showed two episodes of noise and oversensing which resulted in pacing inhibition.Ventricular threshold trends showed increased threshold measurements and decreased pacing impedance measurements over the past two months.Additionally, farfield r wave oversensing (ffrwos) caused false atrial tachycardia response (atr) storage.A boston scientific technical services consultant recommended in office assessment of the rv lead.The model, serial and manufacturer of the rv lead is unknown.No adverse patient effects were reported.It was reported that an alert had been generated for a rv pacing impedance measurement greater than 3000 ohms.Additionally, loss of capture was observed on the presenting egm.The clinical observations were documented, and no adverse patient effects were reported.

Event Description

It was reported that an alert had been generated for this system for out-of-range intrinsic amplitude measurements on the right ventricular (rv) channel.Stored electrograms (egms) showed two episodes of noise and oversensing which resulted in pacing inhibition.Ventricular threshold trends showed increased threshold measurements and decreased pacing impedance measurements over the past two months.Additionally, farfield r wave oversensing (ffrwos) caused false atrial tachycardia response (atr) storage.A boston scientific technical services consultant recommended in office assessment of the rv lead.The model, serial and manufacturer of the rv lead is unknown.No adverse patient effects were reported.It was reported that an alert had been generated for a rv pacing impedance measurement greater than 3000 ohms.Additionally, loss of capture was observed on the presenting egm.The clinical observations were documented, and no adverse patient effects were reported.This report is being submitted to update the model and serial number of the product in question.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18956018
• MDR Text Key: 338368239
• Report Number: 2124215-2024-17361
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960006/S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2024
• 2 Devices were Involved in the Event: 1 2

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: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 04/24/2024
• Supplement Dates FDA Received: 05/02/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR