MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS PATIENT ELECTRONICS SYSTEM(LAND LINE)

Model Number	CM1010
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
It was reported the patient observed sparks coming out and a burning smell while attempting to power on the unit.The unit was replaced which resolved the issue.

• Brand Name: CARDIOMEMS PATIENT ELECTRONICS SYSTEM(LAND LINE)
• Common Device Name: CARDIOMEMS PATIENT ELECTRONICS SYSTEM(LAND LINE)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. - CARDIOMEMS; 387 technology circle nw suite 500; atlanta GA 30313
• MDR Report Key: 8001928
• Report Number: 3004936110-2018-01078
• Device Sequence Number: 19215265
• Product Code: MOM
• UDI-Device Identifier: 05414734509176
• UDI-Public: 05414734509176
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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: CM1010
• Device Catalogue Number: CM1010
• Device Lot Number: N032711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1