MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM); CARDIOMEMS PATIENT ELECTRONIC SYSTEM

Model Number	CM1000
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is included in the error 5 advisory notice issued by abbott on (b)(6) 2018.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 that the patient electronic unit received an error 5 message, which indicates an issue related to temperature and barometric pressure.A replacement unit may resolve the issue.

• Brand Name: CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM)
• Common Device Name: CARDIOMEMS PATIENT ELECTRONIC SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. - CARDIOMEMS; 387 technology circle nw suite 500; atlanta GA 30313
• MDR Report Key: 7627765
• Report Number: 3004936110-2018-00586
• Device Sequence Number: 1277468
• Product Code: MOM
• UDI-Device Identifier: 05414734509169
• UDI-Public: 05414734509169
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: CM1000
• Device Catalogue Number: CM1000
• Device Lot Number: 5131264
• 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: 05/24/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004936110-06/01/18-001R
• Patient Sequence Number: 1
• Patient Age: 51 YR