MAUDE Adverse Event Report: Abbott Medical CARDIOMEMS PATIENT ELECTRONIC SYSTEM; System, Hemodynamic, Implantable

Model Number	CM1100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an incidental finding during product analysis confirming physical damage to the cardiomems i3 printed circuit board.Damaged area with a hole was discovered on a conductor on the i3 printed circuit board.Damage resulted in potential for exposed low voltage components.
Additional Manufacturer Narrative
After performing multiple diagnostic tests and observing multiple failures, the unit was disassembled for further inspection.During disassembly, a damaged area with a hole was discovered on the pcb board.The damaged conductor was identified at u34.A standard power supply was connected to the unit.The unit was powered on with no sparking or thermal issues observed.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.

• Brand Name: CARDIOMEMS PATIENT ELECTRONIC 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: 50478828
• Report Number: 3004936110-2026-01508
• Device Sequence Number: 15995791
• Product Code: MOM
• UDI-Device Identifier: 05414734509800
• UDI-Public: (01)05414734509800(10)5767151
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: Lay User/Patient
• Device Model Number: CM1100
• Device Catalogue Number: CM1100
• Device Lot Number: 5767151
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown