MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3000
Medical Device Problem Codes	Failure to Read Input Signal (1581); No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiomems implant procedure was aborted due to hospital electronics system signal acquisition issues.The rhc and lhc procedures were not being performed primarily for the implant.The patient was implanted 5 days later without incident.
Additional Manufacturer Narrative
One cardiomems hospital electronic system with model name cm3000 and sn (b)(6) was received for evaluation.Visual inspection determined that there was no physical external damage to the device.The reported event that the device had "signal acquisition issues" was confirmed.During initial testing, the device was not able to pass the button tests or the accuracy and distance tests.The wand was opened up, and it was determined that the j1 connecter was partially disconnected.The root cause of the reported issue was determined to be a partially disconnected j1 connecter within the device wand.During investigation, it was noted that the device had passed expected product lifetime of 5 years as stated in the ifu.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): ST. JUDE MEDICAL, INC.; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: melissa wappel ; 14900 minnetonka industrial road; minnetonka, MN 55345 ; 6517565400
• MDR Report Key: 18949495
• Report Number: 3004936110-2024-00422
• Device Sequence Number: 15445161
• Product Code: MOM
• UDI-Device Identifier: 05414734509244
• UDI-Public: 05414734509244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: Other
• Device Model Number: CM3000
• Device Catalogue Number: CM3000
• Device Lot Number: 6791393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White