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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. - CARDIOMEMS PROCLAIM 5 ELITE; SCS IPG
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ST. JUDE MEDICAL, INC. - CARDIOMEMS PROCLAIM 5 ELITE; SCS IPG Back to Search Results
Model Number 3660
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative
The device is included in the error 5 advisory notice issued by abbott on 01 june 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 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
PROCLAIM 5 ELITE
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL, INC. - CARDIOMEMS
387 technology circle nw suite 500
atlanta GA 30313
MDR Report Key7626236
MDR Text Key111917225
Report Number3004936110-2018-00533
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734509800
UDI-Public05414734509800
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3660
Device Lot Number6170171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487-060217-001-C
Patient Sequence Number1
Treatment
MODEL 1192, SCS ANCHOR; MODEL 1192, SCS ANCHOR; MODEL 3189, SCS LEAD; MODEL 3189, SCS LEAD; MODEL 1192, SCS ANCHOR; MODEL 1192, SCS ANCHOR; MODEL 3189, SCS LEAD; MODEL 3189, SCS LEAD
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