MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problems High impedance (1291); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, this device exhibited high, out of range pacing impedance (>3000 ohms) when connected to the left ventricular (lv) lead.The lv lead was disconnected and tested using a pacing system analyzer (psa), which showed normal impedance measurements.However, once reconnected to the device, the pacing impedance was again >3000 ohms.The physician elected to exchange the device to resolve the event and when connected to the new replacement device, all electrical measurements were stable and within range.The device is expected for analysis, but has not yet been received.The patient was stable with no adverse consequences.

Event Description

It was reported that during the implant procedure, this device exhibited high, out of range pacing impedance (>3000 ohms) when connected to the left ventricular (lv) lead.The lv lead was disconnected and tested using a pacing system analyzer (psa), which showed normal impedance measurements.However, once reconnected to the device, the pacing impedance was again >3000 ohms.The physician elected to exchange the device to resolve the event and when connected to the new replacement device, all electrical measurements were stable and within range.The device is expected for analysis, but has not yet been received.The patient was stable with no adverse consequences.

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.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.This device passed all returned product testing; however, boston scientific has initiated an investigation into the behavior described in the event description, including consideration of potential design enhancements, as deemed appropriate.

• Brand Name: RESONATE X4 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
• MDR Report Key: 10322822
• MDR Text Key: 200317942
• Report Number: 2124215-2020-15476
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 237246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 03/22/2021
• Patient Sequence Number: 1