MAUDE Adverse Event Report: ABBOTT MEDICAL CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3000
Medical Device Problem Codes	Material Frayed (1262); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User at the clinic noticed the hospital electonics system has slightly frayed wires on the back of the unit.The hospital electronics system was replaced and there were no adverse consequences reported by the user at the clinic.
Additional Manufacturer Narrative
The investigation codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
One cardiomems hospital electronic system was received for evaluation.The reported event that the hospital electronic system (hes) had frayed wires on the back of the device was not able to be confirmed.No wires that attach to the back of the device were returned, and a visual inspection was not able to be performed on the wires referenced.Additionally, the returned antenna had no frays on the cable.During investigation, it was noted that device (b)(6) had passed expected product life-time of 5 years as stated in the ifu.The reported event that the returned antenna was making a noise was not able to be confirmed.Visual inspection of the antenna paddle was not able to reproduce any noise uncommon to the device.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 HOSPITAL ELECTRONICS SYSTEM
• Common Device Name: SYSTEM, HEMODYNAMIC, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ABBOTT MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: todd mitchell ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 21772217
• Report Number: 3004936110-2025-00595
• Device Sequence Number: 20898833
• Product Code: MOM
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: CM3000
• Device Catalogue Number: CM3000
• Device Lot Number: 7186313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• 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 Sex: Unknown