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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number H403023
Device Problem Loss of Threshold (1633)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received into the lab for analysis.  preliminary measurements confirmed system voltages to be within the specified limits and no discoloration of the power supply wiring connector was observed. It was also confirmed that the stimulator successfully executed the post (power on self-test) and communicated with the ep-4 touchscreen pc. The returned cardiac stimulator was then subjected to an extended pacing test which resulted in the loss of communication reported. Additional testing isolated the root cause of the communication issue to the single board compute. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. No rework or non-conformances associated with the reported event were identified. Based on the information provided to abbott and the investigation performed, the root cause of the reported communication issue was isolated to abnormal functionality of the microprocessor.
 
Event Description
During the procedure, the ep-4 was intermittently stopped pacing while attempting to pace the phrenic nerve. While intermittent pacing occurred the screen of the stimulator was show that the unit was still on. After pacing returned, the system would return to the home screen in the middle of the procedure. When pacing returned, the procedure was able to be completed with no adverse patient consequences.
 
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Brand NameWORKMATE CLARIS EP-4 CARDIAC STIMULATOR
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key12347765
MDR Text Key267445460
Report Number2184149-2021-00252
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092913
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH403023
Device Catalogue NumberH403023
Device Lot Number7061297
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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