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

Model Number L331

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Connection Problem (2900); Device Sensing Problem (2917); Data Problem (3196)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient underwent a recent elective procedure to replace his implantable device.One week post implant, an alert was generated for pacing impedance measurements greater than 3000 ohms on the chronic right ventricular (rv) lead.The lead configuration was automatically reprogrammed from bipolar to unipolar due to the lead safety switch (lss) which occurred due to the out-of-range impedance.Lead testing was performed in both unipolar and bipolar configurations.Pacing impedance was greater than 3000 ohms, sensing was unremarkable, and threshold measurements could not be obtained in bipolar mode.However, pacing impedance was 400 ohms, sensing was 6.7mv, and threshold was 0.7v @ 0.4ms in unipolar mode.No noise was observed, and no pacing inhibition was observed with isometric exercises.Fluoroscopy was performed and identified the lead was under inserted in the rv port of the pacemaker.The patient was admitted to the hospital for a procedure to secure the lead in the device header.The connection was secured; however, impedance measurements were still out of range during testing with the device and using a pacing system analyzer (psa).Additionally, noise was observed when the distal pin of the lead was manipulated, and no capture could be obtained despite maximum device output.Further inspection confirmed the lead was fractured.Therefore, the lead was removed from service and surgically abandoned.A replacement lead was implanted with satisfactory sensing and pacing results.No additional adverse patient effects were reported.

• 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18744599
• MDR Text Key: 335810867
• Report Number: 2124215-2024-10231
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

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: Health Professional
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 624011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male