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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM)
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ST. JUDE MEDICAL, INC. - CARDIOMEMS CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM) Back to Search Results
Model Number CM1000
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/29/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is included in the error 5 advisory notice issued by abbott on 01 june 2018.
 
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.
 
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Brand Name
CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM)
Common Device Name
CARDIOMEMS PATIENT ELECTRONICS SYSTEM(GSM)
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. - CARDIOMEMS
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key8147623
Report Number3004936110-2018-02025
Device Sequence Number19350305
Product Code MOM
UDI-Device Identifier05414734509169
UDI-Public05414734509169
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P100045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 04/17/2019
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 NumberCM1000
Device Catalogue NumberCM1000
Device Lot Number5129169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/30/2018
Supplement Date Received by Manufacturer04/16/2019
Initial Report FDA Received Date12/10/2018
Supplement Report FDA Received Date04/17/2019
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 Number1
Patient Age73 YR
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