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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ CATHETER INTERFACE MODULE/PINBOX; CARDIAC CATHETERIZATION MONITORING SYSTEM
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ST. JUDE MEDICAL, INC. EP-WORKMATE¿ CATHETER INTERFACE MODULE/PINBOX; CARDIAC CATHETERIZATION MONITORING SYSTEM Back to Search Results
Device Problems Power Conditioning Problem (1474); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record for the above-referenced product was unable to be reviewed since the batch number is unknown.
 
Event Description
During a supraventricular tachycardia ablation procedure, noise was noted on the signals while pacing and the procedure was cancelled.There were no patient consequences.
 
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Brand Name
EP-WORKMATE¿ CATHETER INTERFACE MODULE/PINBOX
Type of Device
CARDIAC CATHETERIZATION MONITORING SYSTEM
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6813248
MDR Text Key83494509
Report Number2184149-2017-00020
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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