MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G179

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that, during device interrogation, this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range shock impedance measurements, measuring greater than 128 ohms.All other measurements were stable.Boston scientific technical services also noted that the shock impedance alert was triggered approximately 2 months prior where patient received an anti-tachycardia pacing (atp) therapy with shock impedances high out of range greater than 125 ohms.There was no oversensing.Technical services discussed possible causes and provided programming options.Health care professional (hcp) will discuss plan with cardiologist and continue to monitor this patient.No adverse patient effects were reported.This product remains in service.

Event Description

It was reported that, during device interrogation, this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range shock impedance measurements, measuring greater than 128 ohms.All other measurements were stable.Boston scientific technical services also noted that the shock impedance alert was triggered approximately 2 months prior where patient received an anti-tachycardia pacing (atp) therapy with shock impedances high out of range greater than 125 ohms.There was no oversensing.Technical services discussed possible causes and provided programming options.Health care professional (hcp) will discuss plan with cardiologist and continue to monitor this patient.No adverse patient effects were reported.This product remains in service.Additional information was provided on 19oct2021, it was reported that this cardiac resynchronization therapy defibrillator (crt-d) triggered a high out of range pacing impedance measurement, measuring greater than 3000 ohms in the right atrial channel upon device interrogation.Review of past trend noted multiple out of range atrial lead impedances and episodes of noise was recorded.Shock lead impedance had occasional increases to over 125 ohms, but mostly impedances were less than 100 ohms.Boston scientific technical services provided information to healthcare professional and discussed probable causes.No adverse patient effects were reported.This crt-d, competitor right atrial and competitor right ventricular lead remains in service.

Manufacturer Narrative

Additional information was provided in section b5 and h10.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.Engineering analysis and testing of returned products identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: AUTOGEN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 11104593
• MDR Text Key: 224804838
• Report Number: 2124215-2020-25290
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 01/06/2022

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
• Device Expiration Date: 12/03/2016
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 127957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 01/02/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female