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

Model Number G247

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Pacing Problem (1439); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Date 07/24/2020

Event Type  Injury  

Event Description

It was reported that during a device change out procedure this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range pacing impedances on the left ventricular (lv) lead measuring greater than 3000 ohms and noise was observed when connected to the device.When the lv lead was connected to the with pacing system analyzer (psa) the measurements appeared to be normal.The physician tried multiple attempts of reinserting into the header, and had difficulties inserting it, and after tightening the setscrews there was noise observed on the lv channel.No other leads were effected.It was suspected there was a header connection issue with the lv port.It was also noted that there were observations of brady pacing not delivered when required and high thresholds.Subsequently, this crt-d was removed and replaced successfully.This device was returned for lab analysis.No additional adverse patient effects were reported.

Event Description

It was reported that during a device change out procedure this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range pacing impedances on the left ventricular (lv) lead measuring greater than 3000 ohms and noise was observed when connected to the device.When the lv lead was connected to the with pacing system analyzer (psa) the measurements appeared to be normal.The physician tried multiple attempts of reinserting into the header, and had difficulties inserting it, and after tightening the setscrews there was noise observed on the lv channel.No other leads were effected.It was suspected there was a header connection issue with the lv port.It was also noted that there were observations of brady pacing not delivered when required and high thresholds.Subsequently, this crt-d was removed and replaced successfully.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.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.

• Brand Name: VIGILANT 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: 10619694
• MDR Text Key: 209576108
• Report Number: 2124215-2020-16487
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• 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: 04/16/2021

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: 07/01/2022
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 240183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR