MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? EL ICD DR; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	D121
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Shock from Patient Lead(s) (3162)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had reached battery capacity depleted (bcd) after less than 1.5 years of implant and recorded a code 1007, indicative of charge time that had exceeded 45 seconds.The patient was at physical therapy the day before, and received multiple shocks.The patient was transported to the emergency department while he was still conscious.The patient then received numerous additional shocks, went into pulseless electrical activity, and was now intubated.The last capacity reform was in (b)(6) 2026 with a charge time (ct) of 10.9 seconds, with 0.56 amp hours remaining.A longevity estimate from (b)(6) 2026 showed approximately 11.5 years remaining, and had not yet taken into account 188 delivered shocks and 85 diverted shocks from (b)(6) 2026.A review of some of those episodes showed true ventricular tachycardia (vt).Technical services (ts) discussed that the code 1007 was attributed to the high volume of shocks delivered, requiring significant battery consumption.This icd remains implanted, however emergent device replacement was recommended.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: MOMENTUM? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (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 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: 50384377
• Report Number: 2124215-2026-45255
• Device Sequence Number: 9789672
• Product Code: LWS
• UDI-Device Identifier: 00802526587726
• UDI-Public: (01)00802526587726(17)260219
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: 02/19/2026
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 244821
• 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: 08/22/2026
• Date Device Manufactured: 02/29/2024
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male