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

Model Number	CM1100
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During device analysis, it was found that the patient electronics system handheld cable had frayed and exposed wires.
Additional Manufacturer Narrative
One cardiomems patient electronic system was received for evaluation.Visual inspection of returned material revealed frayed and exposed wires on the handheld cable.Using a golden handheld cable, power-on was successful and unit passed all portions of diagnostic including formatted compact, signal acquisition and handheld portion of test.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: 50932030
• Report Number: 3004936110-2026-01674
• Device Sequence Number: 10749257
• Product Code: MOM
• UDI-Device Identifier: 05414734509800
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 10623423
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male