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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ STIMULATOR CABLE; CARDIAC CATHETERIZATION MONITORING SYSTEM
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ST. JUDE MEDICAL, INC. EP-WORKMATE¿ STIMULATOR CABLE; CARDIAC CATHETERIZATION MONITORING SYSTEM Back to Search Results
Device Problem No Pacing (3268)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2018
Event Type  Injury  
Event Description
During an electrophysiology procedure for non-sustained ventricular tachycardia, a cancellation occurred as pacing was not possible.The patient was prepped and the procedure was stopped.There were no adverse patient consequences.
 
Manufacturer Narrative
One workmate¿ claris¿ system ep-4¿ stim cable was received.Physical damage was observed to several connectors which are missing part of the connector body at the channel one, two and three locations.Based on the information provided to abbott and the investigation performed, the root cause of the reported cancellation was isolated to physical damage to several connectors of the cardiac stimulator cable.
 
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Brand Name
EP-WORKMATE¿ STIMULATOR CABLE
Type of Device
CARDIAC CATHETERIZATION MONITORING SYSTEM
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
MDR Report Key7714917
MDR Text Key114863462
Report Number2184149-2018-00113
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
PMA/PMN Number
K151911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight137
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