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

Model Number	CM1100
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The investigation of the device revealed a finding of frayed and exposed wires on the power extension cable of the device.The patient electronic unit was replaced and there were no adverse consequences reported by the patient.
Additional Manufacturer Narrative
Fa-q323-hf-4 cardiomems pes right angle power extension cable failure notice issued by abbott on 04 oct 2023.One cardiomems patient electronic system was received for evaluation.External visual inspection of returned material revealed exposed and frayed wires on the right ang ext cable.No additional physical damage was observed.The backplate of the device was removed and a standard power supply was connected.The unit was powered on with no 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.

• 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: 50801505
• Report Number: 3004936110-2026-01621
• Device Sequence Number: 10610444
• Product Code: MOM
• UDI-Device Identifier: 05414734509800
• UDI-Public: (01)05414734509800(10)10391418
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Company Representative
• Remedial Action: Notification
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: CM1100
• Device Catalogue Number: CM1100
• Device Lot Number: 10391418
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q323-HF-4
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male