MAUDE Adverse Event Report: Abbott Medical HF Sensor Delivery System; System, Hemodynamic, Implantable

Model Number	CM2000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A right heart catheterization was performed to confirm the validity of the pressure sensor readings.The sensor was recalibrated, and the mean was increased by 4.8 mmhg.Readings were observed under the manufacturer's patient care network database.
Additional Manufacturer Narrative
No device analysis results are available because the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Per the instructions for use, right heart catheterization is required for system baseline (mean pressure) calibration and may be needed to recalibrate the baseline (mean pressure) in order to continue to use the system.

• Brand Name: HF Sensor Delivery System
• Common Device Name: System, Hemodynamic, Implantable
• Manufacturer (Section D): Abbott Medical; 387 nerem st nw suite 500; atlanta GA 30313
• Manufacturer (Section G): Abbott Medical; 387 nerem st nw suite 500; atlanta GA 30313
• Manufacturer Contact: fredric gold ; 168 middlesex turnpike; burlington, MA 01803 ; +1(651)756-5400
• MDR Report Key: 50457083
• Report Number: 3004936110-2026-01458
• Device Sequence Number: 10487225
• Product Code: MOM
• UDI-Device Identifier: 05414734509237
• UDI-Public: (01)05414734509237(10)9151351(17)250803
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Model Number: CM2000
• Device Catalogue Number: CM2000
• Device Lot Number: 9151351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 272 LB