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

Model Number	CM2000
Medical Device Problem Code	Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was confirmed by the technical heart failure specialist team that the patient's cardiomems waveforms were dampened.The physician is currently monitoring the patient and the sensor readings.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The investigation codes along with investigation results will be provided in a subsequent submission.

• 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: 50786939
• Report Number: 3004936110-2026-01506
• Device Sequence Number: 10529674
• Product Code: MOM
• UDI-Device Identifier: 05414734509237
• UDI-Public: (01)05414734509237(10)10265864(17)260326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: Health Professional
• Device Expiration Date: 03/26/2026
• Device Model Number: CM2000
• Device Catalogue Number: CM2000
• Device Lot Number: 10265864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male