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

Model Number G140

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 04/02/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones due to high out-of-range (oor) shock impedances on the right ventricular (rv) lead, measuring 125 ohms.Boston scientific technical services (ts) recommended reprogramming the oor upper limit alert to 150 ohms.This crt-d and rv lead remain in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones due to high out-of-range (oor) shock impedances on the right ventricular (rv) lead, measuring 125 ohms.Boston scientific technical services (ts) recommended reprogramming the oor upper limit alert to 150 ohms.This crt-d and rv lead remain in service.No adverse patient effects were reported.The crt-d was explanted and returned to boston scientific.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones due to high out-of-range (oor) shock impedances on the right ventricular (rv) lead, measuring 125 ohms.Boston scientific technical services (ts) recommended reprogramming the oor upper limit alert to 150 ohms.This crt-d and rv lead remain in service.No adverse patient effects were reported.The crt-d was explanted and returned to boston scientific.No additional adverse patient effects were reported.

• Brand Name: INOGEN CRT-D
• 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: 10089638
• MDR Text Key: 192153432
• Report Number: 2124215-2020-07028
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2017
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 476710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 09/21/2022; 10/03/2022
• Supplement Dates FDA Received: 09/29/2022; 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female