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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, 4 CHANNEL EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC. EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 09-1527-0000
Device Problem Device Operational Issue (2914)
Patient Problem Arrhythmia (1721)
Event Date 03/28/2017
Event Type  Injury  
Event Description
During an atrioventricular nodal reentrant tachycardia procedure, the patient went into torsades de pointes. An abbott decapolar catheter was in the right ventricle which was used for the (b)(6) study without issue. The patient decompensated and went into a rhythm of torsades de pointes which spontaneously converted and vitals returned to normal. The case continued with no further issues. Following review of the event on the non abbott recording system, pacing spikes were noted and it was suspected the ep4 stimulator was pacing without the user initiating pacing. The patient left the lab in stable condition.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with abbott specifications and procedures. Based on the information received, the cause of the reported torsades de pointes could not be conclusively determined. Per the ifu, arrhythmia is a known risk during the use of this device.
 
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Brand NameEP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL
Type of DeviceEXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR
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 Key6523752
MDR Text Key73780329
Report Number2184149-2017-00006
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K092913
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number09-1527-0000
Other Device ID Number05414734030236
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2013
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: 04/26/2017 Patient Sequence Number: 1
Treatment
ABBOTT DECAPOLAR CATHETER; AMPERE RF ABLATION GENERATOR; ENSITE VELOCITY CARDIAC MAPPING SYSTEM; GE RECORDING SYSTEM
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