MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE? HF ICD VR; implantable cardioverter defibrillator (ICD)

Model Number	D532
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Unspecified Infection (1930); Syncope/Fainting (4411)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead experienced a syncopal episode.Technical services (ts) was consulted and reviewed the available information, noting that shock impedance measurements had been trending upward while remaining within normal limits.Subsequently, the patient developed an infection that necessitated extraction of the icd and rv lead.These products have not been returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: RESONATE? HF ICD VR
• Common Device Name: implantable cardioverter defibrillator (ICD)
• 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: 50798180
• Report Number: 2124215-2026-49605
• Device Sequence Number: 16095992
• Product Code: LWS
• UDI-Device Identifier: 00802526588280
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: D532
• Device Catalogue Number: D532
• Device Lot Number: 360643
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/25/2025
• 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; Other
• Patient Age: 58 YR
• Patient Sex: Female