MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L311

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Connection Problem (2900)

Patient Problems Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.(b)(4).

Event Description

It was reported that this patient experienced a syncopal event.A review of the device data identified a lead safety switch had been triggered due to a pacing impedance measurement greater than 3000 ohms on the right ventricular (rv) channel.Additionally, noise and oversensing was observed on the rv channel with noise on the atrial channel as well.Testing was performed and impedance, threshold and sensing measurements were within normal limits.However, noise was present on both channels during isometrics and when the device was touched.A revision procedure was performed to replace the rv lead and fluoroscopy revealed the lead was loose from the device header.Visual inspection when the pocket was opened also confirmed the terminal pin was loose but still securely connected.Both leads were removed from the device header and testing was performed utilizing a pacing system analyzer.Measurements were within normal limits and there was no presence of noise.The rv lead was re-connected to the device and the noise observed in the previous follow up visit was no longer observed.The physician suspected the device had expanded with air which resulted in the reported clinical observations.The device was explanted and replaced and the leads remain in service.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.A hole was noted in the right atrial seal plug.This is unlikely to be related to noise observed clinically which was reported to have occurred well after implant.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the 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

This supplemental report is being filed due to the completed evaluation of this product.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11206869
• MDR Text Key: 227917960
• Report Number: 2124215-2020-28642
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: 05/17/2021
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 427794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR