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

Model Number L331

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Low impedance (2285)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that this pacemaker was found to be in safety mode in which there were observations of a separate integrated circuit issues causing premature battery depletion, low right atrial (ra) pacing lead impedances however, impedance measurements are within normal range, and failed ra threshold testing.A request was made for engineering analysis and the cause of the high-power consumption is uncertain.The power consumption jumped, and the ra lead impedance dropped approximately 10 days after the ra pacing began.The right ventricular (rv) pacing impedances appears to be unaffected.Technical services recommended to replace the device and ra lead.The field representative will discuss with the physician.At this time, the system remains in service.No adverse patient effects were reported.

Event Description

It was reported that this pacemaker was found to be in safety mode in which there were observations of a separate integrated circuit issues causing premature battery depletion, low right atrial (ra) pacing lead impedances however, impedance measurements are within normal range, and failed ra threshold testing.A request was made for engineering analysis and the cause of the high-power consumption is uncertain.The power consumption jumped, and the ra lead impedance dropped approximately 10 days after the ra pacing began.The right ventricular (rv) pacing impedances appears to be unaffected.Technical services recommended to replace the device and ra lead.The field representative will discuss with the physician.At this time, the system remains in service.No adverse patient effects were reported.Additional information was received which reported the patient fell and the patient advocate was concerned about an issue with the leads when the patient was picked up.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this pacemaker was found to be in safety mode in which there were observations of a separate integrated circuit issues causing premature battery depletion, low right atrial (ra) pacing lead impedances however, impedance measurements are within normal range, and failed ra threshold testing.A request was made for engineering analysis and the cause of the high-power consumption is uncertain.The power consumption jumped, and the ra lead impedance dropped approximately 10 days after the ra pacing began.The right ventricular (rv) pacing impedances appears to be unaffected.Technical services recommended to replace the device and ra lead.The field representative will discuss with the physician.At this time, the system remains in service.No adverse patient effects were reported.Additional information was received which reported the patient fell and the patient advocate was concerned about an issue with the leads when the patient was picked up.At this time, the device remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this pacemaker was explanted, and the right atrial (ra) lead was surgically abandoned.A new pacemaker and rv lead was implanted successfully.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to field b5 describe event or problem.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18987503
• MDR Text Key: 338760269
• Report Number: 2124215-2024-18532
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 610476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male