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

Model Number	CM3000
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to the implant procedure with the patient already on the table with venipuncture, the hospital electronics system was not able to pass the dynamic signal check and the procedure had to be cancelled.Multiple troubleshooting efforts were attempted, however, ultimately the issue could not be resolved.There were no adverse consequences to the patient due to the cancelled procedure and the procedure was rescheduled for approximately four to five weeks later.
Additional Manufacturer Narrative
One cardiomems hospital electronics system was received for investigation.Internal visual inspection of unit¿s rigid antenna revealed the amp connector of the rigid antenna cable was not fully connected to the rigid antenna main stuffed pcb.The unit did not pass all frequencies in signal acquisition test steps accuracy/ noise home and distance home of initial diagnostic test.The unit passed button and signal acquisition test steps of a subsequent diagnostic test after the amp connector of the rigid antenna cable was fully connected to rigid antenna main stuffed pcb inside of the rigid antenna.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.
Event or Problem Description
Prior to the implant procedure with the patient already on the table with venipuncture, the hospital electronics system was not able to pass the dynamic signal check and the procedure had to be cancelled.Multiple troubleshooting efforts were attempted, however, ultimately the issue could not be resolved.There were no adverse consequences to the patient due to the cancelled procedure and the procedure was rescheduled for (b)(6) 2023.

• Brand Name: CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM
• Common Device Name: SYSTEM, HEMODYNAMIC, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer (Section G): ST. JUDE MEDICAL; 387 technology circle nw suite 500; atlanta GA 30313
• Manufacturer Contact: bob fryc ; one st. jude medical drive; st. paul, MN 55117 ; 6517565400
• MDR Report Key: 16350291
• Report Number: 3004936110-2023-00156
• Device Sequence Number: 17843344
• Product Code: MOM
• UDI-Device Identifier: 05415067029331
• UDI-Public: 05415067029331
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/29/2023

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: Health Professional
• Device Model Number: CM3000
• Device Catalogue Number: CM3000
• Device Lot Number: 8382469
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 66 KG