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

Model Number G247

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Material Integrity Problem (2978)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the was noise on both the right ventricular (rv) rate sense and shock channels.Oversensing of the noise led to non sustained episodes and pacing inhibition, however the patient had any underlying rate.There were also pacemaker mediated tachycardia (pmt) episodes stored, but no oversensing noted on those episodes.The noise was thought to be due to myopotentials based upon patient's movement as no noise was seen when performing pocket manipulation.The rv sensitivity was reduced to 1.0 millivolts and the ventricular fibrillation (vf) duration was extended to four seconds.They increased the remote home monitoring frequency to monthly.Approximately seven months later the oversensing of noise continued.Boston scientific technical services (ts) was consulted and suggested induction testing.The field representative noted the physician chose not to perform induction testing and will continue to monitor the patient via the remote home monitoring system.Approximately six months later the patient underwent a revision procedure due to continued noise.Upon pocket opening there was damage noted to the cardiac resynchronization therapy defibrillator (crt-d) rv seal plug.Ts recommended replacement of the device as seal plug damage could cause noise.The crt-d was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that the was noise on both the right ventricular (rv) rate sense and shock channels.Oversensing of the noise led to non sustained episodes and pacing inhibition, however the patient had any underlying rate.There were also pacemaker mediated tachycardia (pmt) episodes stored, but no oversensing noted on those episodes.The noise was thought to be due to myopotentials based upon patient's movement as no noise was seen when performing pocket manipulation.The rv sensitivity was reduced to 1.0 millivolts and the ventricular fibrillation (vf) duration was extended to four seconds.They increased the remote home monitoring frequency to monthly.Approximately seven months later the oversensing of noise continued.Boston scientific technical services (ts) was consulted and suggested induction testing.The field representative noted the physician chose not to perform induction testing and will continue to monitor the patient via the remote home monitoring system.Approximately six months later the patient underwent a revision procedure due to continued noise.Upon pocket opening there was damage noted to the cardiac resynchronization therapy defibrillator (crt-d) rv seal plug.Ts recommended replacement of the device as seal plug damage could cause noise.The crt-d was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed.Visual examination identified no rv seal plug and it appeared that part of the seal plug had been cut away/torn away from the header.The medical adhesive (ma) was still attached to the header around the seal plug port and some of the remaining ma was a little loose while some was still solidly attached.There was body fluid contamination in the rv seal plug port, in the distal area of the rv lead barrel and on the rv terminal block.Next, the defibrillation, pacing, and sensing functions of the device were verified to be operating normally.A review of a stored device electrogram showed no noise on the ventricular channel.Analysis determined that the seal plug damage and body fluid intrusion into the rv terminal block was confirmed.The event occurred about three months after implant.The issues continued to show until the decision to explant.Analysis determined this was consistent with temporary body fluid infiltration through the seal plug, coupled with air escaping the seal plug.Setscrew seal plugs are designed to permit setscrew wrench insertion yet prevent body fluids from entering the header cavities.If an accessory sensing pathway is present due to fluid intrusion, there is a potential for oversensing and, thus, inhibition of pacing or delivery of inappropriate therapy.Patient code 3191 captures the reportable event of surgery.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: VIGILANT 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: 11103670
• MDR Text Key: 224758848
• Report Number: 2124215-2020-24257
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 214652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 07/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR