MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE DEVICE

Model Number L311

Device Problems Failure to Capture (1081); Failure to Sense (1559); Under-Sensing (1661); High Capture Threshold (3266)

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

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker device and the associated right atrial (ra) lead were explanted and replaced ten days after they were initially implanted.It was noted that during routine follow-up, there was undersensing and high thresholds observed, and the ra lead appeared to be stable and well-fixated via fluoroscopy, but device testing showed there was no sensing and no capture at maximum output.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.The device was 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 based on completion of device analysis.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11104513
• MDR Text Key: 224746250
• Report Number: 2124215-2020-26399
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• 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
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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: 08/20/2022
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 506509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 01/02/2021
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR