MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEVICE

Model Number G447

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Pocket Stimulation (1463); Low impedance (2285); High Capture Threshold (3266)

Patient Problem Muscle Stimulation (1412)

Event Date 07/07/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead exhibited high threshold measurements, loss of capture (loc) and low out of range pacing impedance measurements less than 200 ohms 13 days post implant.Additionally, the device showed a battery status of 1 year remaining.The lead configuration was reprogrammed and capture was obtained, however, the patient experienced muscle stimulation, so the lead was programmed off.A copy of device memory was submitted for analysis.Analysis of device memory noted a high power consumption condition and device replacement was recommended and troubleshooting options were discussed for the lv lead.An invasive procedure was performed.The pocket was opened and lead to device header connections were verified to be appropriate.The device was explanted.The lv lead was then tested on a pacing system analyzer (psa) and pacing impedance measurements were noted to be within normal limits at 297-317 ohms.The lead position was verified to be appropriate under fluoroscopy.The lead configuration was reprogrammed and appropriate capture was observed with no stimulation.A new device was successfully implanted with the chronic lv lead.No additional adverse patient effects were reported.

Manufacturer Narrative

Detailed testing isolated the high current condition to an anomaly of the transistor gate oxide within the analog pacing block.The oxide glass layer is intended to serve as a non-conductive insulator, but unintended metal impurities in the glass layer can create an inappropriate conductive pathway between two adjacent conductive metal layers.Also, because these layers are very thin, empty voids or bubbles within the glass can provide a pathway for current leakage if sufficient voltage is applied to the conductive layers on either side of the void.This pathway can be latent with minuscule current leakage.Over time, voltage stress can increase current leakage, which may alter component/device function, increase overall current drain, and deplete the battery prematurely.Boston scientific has worked with integrated circuit manufacturers to implement continuous manufacturing improvements over time to reduce oxide defects, such as improving purity of the materials used, tightening manufacturing clean room particle count specifications, and improving handling and inspection techniques.The supplier implemented a hydrochloric acid (hcl) rinse to their manufacturing process in december 2015.However, medical device manufacturers are subject to the inherent limitations of current integrated circuit technologies.Additionally, a test was added to the manufacturing process to identify issues prior to the release of product.

Event Description

It was reported that analysis of this device was completed.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9100591
• MDR Text Key: 159516181
• Report Number: 2124215-2019-17377
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• 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
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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: 04/12/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 214200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR