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

Model Number	D432
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient was scheduled for an implantable cardioverter defibrillator (icd) to cardiac resynchronization therapy defibrillator (crt-d) upgrade procedure with conduction system pacing (csp) lead placement.Csp lead placement was attempted, but there was no capture.The lv lead was removed, and the original icd was placed back into the pocket.Prior to the procedure, in-range shock impedances were noted.After placing the original icd back into the pocket, a low out-of-range shock impedance measurement of 0 ohms was observed.Visual inspection of the chronic right ventricular (rv) defibrillation lead confirmed there was no visible damage, and the physician opted to connect the chronic rv lead with the new icd.A low out-of-range shock impedance measurement of 0 ohms persisted with this new icd, and technical services (ts) was consulted for troubleshooting.Ts recommended turning off the electrocautery grounding pad, which resolved the out-of-range shock impedance measurement.The procedure was completed, and this icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: RESONATE? EL ICD VR
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50600901
• Report Number: 2124215-2026-46787
• Device Sequence Number: 13444873
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)280429
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 649223
• 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: 09/04/2026
• Date Device Manufactured: 05/12/2026
• 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
• Patient Age: 70 YR
• Patient Sex: Male