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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC. EP-WORKMATE EP-4 CARDIAC STIMULATOR COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 09-1463-0120
Device Problem Loss of Threshold (1633)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event was requested but not received.
 
Event Description
During the procedure, the stimulator would not pace through any channel and the procedure was cancelled. The cable was exchanged, the pins were adjusted and the system was restarted with no resolution. The patient was prepped and the procedure was cancelled. The patient was stable with no patient consequences.
 
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Brand NameEP-WORKMATE EP-4 CARDIAC STIMULATOR
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
one st. jude medical drive
st. paul MN 55117
Manufacturer (Section G)
ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
one st. jude medical drive
st. paul MN 55117
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key10081082
MDR Text Key191822764
Report Number2184149-2020-00071
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number09-1463-0120
Device Catalogue Number09-1463-0120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/21/2020 Patient Sequence Number: 1
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