MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL; EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR

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.

• Brand Name: EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL
• Type of Device: EXTERNAL 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 Key: 6523752
• MDR Text Key: 73780329
• Report Number: 2184149-2017-00006
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1527-0000
• Other Device ID Number: 05414734030236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ABBOTT DECAPOLAR CATHETER; AMPERE RF ABLATION GENERATOR; ENSITE VELOCITY CARDIAC MAPPING SYSTEM; GE RECORDING SYSTEM
• Patient Outcome(s): Other
• Patient Weight: 106