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

Model Number	CM2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Cough (4457)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury

• 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: 50896761
• Report Number: 3004936110-2026-01551
• Device Sequence Number: 5904089
• Product Code: MOM
• UDI-Device Identifier: 05414734509237
• UDI-Public: (01)05414734509237(10)11258187(17)280220
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: CM2000
• Device Catalogue Number: CM2000
• Device Lot Number: 11258187
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 279 LB