MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? EL ICD DR; Implantable Lead

Model Number	D121
Medical Device Problem Codes	Signal Artifact/Noise (1036); Under-Sensing (1661); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right atrial (ra) lead was successfully explanted due to a low ra lead impedance and noise, with a gradual decrease in ra impedance to below 200 ohms.The ra lead also demonstrated noise and undersensing, with the findings consistent with a suspected insulation issue and myopotential oversensing.No pacing inhibition occurred, as intrinsic activity was present.The rv lead demonstrated high pacing thresholds, greater than 5 v, with variability in impedance over the previous six months but no out-of-range impedance measurement.Technical services (ts) discussed lead characteristics and sheath sizing considerations with the representative in preparation for the extraction, and the ra and rv leads were addressed as part of the planned procedure.This ra lead was explanted and replaced with another lead.No additional adverse patient effects were reported outside the revision procedure.At this time, this product has not been returned.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: MOMENTUM? EL ICD DR
• Common Device Name: Implantable Lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50331321
• Report Number: 2124215-2026-44695
• Device Sequence Number: 5483304
• Product Code: LWS
• UDI-Device Identifier: 00802526587726
• UDI-Public: (01)00802526587726(17)241124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/24/2024
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 238250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male