MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; PACEMAKER

Model Number L331

Device Problems Failure to Capture (1081); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  Injury  

Event Description

It was reported that this pacemaker system was suspected of exhibiting loss of capture as the patient was in the emergency department due to bradycardia.Technical services (ts) was consulted and reviewed possible reasons for the exhibited issue, leads were non boston scientific products.Noise was not able to be reproduced with isometric maneuver and lead impedance measurements were stable.The pacemaker was reprogrammed, and the thresholds were fixed to 3.5v.Heart rhythm dropped again and the output was fixed to 7.5 v.This pacemaker remains in service.No 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 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.Corrected date of manufacture.

Event Description

It was reported that this pacemaker system was suspected of exhibiting loss of capture as the patient was in the emergency department due to bradycardia.Technical services (ts) was consulted and reviewed possible reasons for the exhibited issue, leads were non boston scientific products.Noise was not able to be reproduced with isometric maneuver and lead impedance measurements were stable.The pacemaker was reprogrammed, and the thresholds were fixed to 3.5v.Heart rhythm dropped again and the output was fixed to 7.5 v.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received and this pacemaker was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this pacemaker system was suspected of exhibiting loss of capture as the patient was in the emergency department due to bradycardia.Technical services (ts) was consulted and reviewed possible reasons for the exhibited issue, leads were non boston scientific products.Noise was not able to be reproduced with isometric maneuver and lead impedance measurements were stable.The pacemaker was reprogrammed, and the thresholds were fixed to 3.5v.Heart rhythm dropped again and the output was fixed to 7.5 v.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received and this pacemaker was explanted.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 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.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16030290
• MDR Text Key: 307586602
• Report Number: 2124215-2022-54301
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2021
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 851638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male