MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM? EL ICD VR; Implantable Cardioverter Defibrillator

Model Number	D120
Medical Device Problem Codes	Premature Discharge of Battery (1057); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system recorded a code 1004 indicative of a short circuit condition during shock delivery.Technical services (ts) reviewed the data and noted there was a ventricular fibrillation (vf) episode.A shock was delivered and converted the rhythm; however, it resulted in a short.Ts analysis also concluded the device did not record a code 1004, but the shock resulted in a low out of range shock impedance measurement.It was also noted this icd system recorded a code 1003, which states that the voltage is too low for projected remaining capacity.The code 1003 was recorded due to the low shocking lead impedance.Ts recommended replacing the entire icd system.It was noted the patient would see the physician to discuss possible system extraction.Additionally, the patient is currently wearing a life vest until future plans are solidified and that tachy therapy was turned off.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: MOMENTUM? EL ICD VR
• Common Device Name: Implantable Cardioverter Defibrillator
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50899894
• Report Number: 2124215-2026-51253
• Device Sequence Number: 6001230
• Product Code: LWS
• UDI-Device Identifier: 00802526587702
• UDI-Public: (01)00802526587702(17)260130
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 01/30/2026
• Device Model Number: D120
• Device Catalogue Number: D120
• Device Lot Number: 220330
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 02/11/2024
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Male