MAUDE Adverse Event Report: ST. JUDE MEDICAL POWER SUPPLY; SYSTEM, HEMODYNAMIC, IMPLANTABLE

Model Number	CM3022
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cardiomems patient electronic system was received for evaluation.Visual inspection of the power supply revealed functional damage to in form of its connector being broken off from the rest of the component.As the connector was broken off, exposed wires were noted.The replacement power supply was used to power on the unit.The cause of the reported damage could not be determined.
Event or Problem Description
This report is to advise of an event observed during analysis confirming exposed wires of the power supply.

• Brand Name: POWER SUPPLY
• 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: 16504232
• Report Number: 3004936110-2023-00252
• Device Sequence Number: 6128964
• Product Code: MOM
• UDI-Device Identifier: 05414734509169
• UDI-Public: 05414734509169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: Lay User/Patient
• Device Model Number: CM3022
• Device Catalogue Number: CM1000
• 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: 03/07/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 83 YR
• Patient Sex: Male