MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM; CARDIAC CATHETERIZATION MONITORING SYSTEM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 04/06/2016

Event Type  Injury  

Event Description

During an av node ablation procedure, asystole occurred.While pacing at a regular cycle length in the right ventricle, it was noted the pacing stopped and the patient went into asystole several times during the procedure.It was thought the pacing button would not work during the procedure.Following the procedure, the case log was analyzed by the user, which revealed the sinus node recovery protocol was inadvertently selected instead of the f5 pacing function, resulting in pacing turning off at the set interval of 30 seconds; therefore, it was determined the system was functioning as intended and no malfunction had occurred.The patient's pacemaker was programmed and the patient was in a paced rhythm at the end of the successfully completed procedure.

Manufacturer Narrative

(b)(4).The case study was returned for evaluation; however, no logs were able to be obtained from the customer.Based on review of the returned case study and the information received, the system functioned as intended.Per the event description, the customer was pacing utilizing the sinus node recovery protocol.Per the sinus node recovery protocol description, the pulse pattern consists of a conditioning train followed by a rest period during which pacing is not applied.It was during use of the sinus node recovery protocol that the patient experienced asystole.Based on this information, the system was operating as intended.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• 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: 5635227
• MDR Text Key: 44559180
• Report Number: 2184149-2016-00003
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151911
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other