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	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's unit had smoke like smell.The patient was not harmed and issue was resolved by replacing the unit.

• 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: 8523217
• Report Number: 3004936110-2019-00203
• Device Sequence Number: 2869068
• Product Code: MOM
• UDI-Device Identifier: 05414734509169
• UDI-Public: 05414734509169
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CM1000
• Device Catalogue Number: CM1000
• Device Lot Number: N012311
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/17/2019
• 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