MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-AMP-02

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Heart Block (4444)

Event Date 03/16/2022

Event Type  Injury  

Event Description

During a supraventricular tachycardia procedure, the patient experienced 2nd degree heart block.Three fixed curve catheters and one steerable decapolar catheter was placed inside the right atrium.Resp.Comp.Was applied and the catheters shifted multiple times.The heart block was transient in nature and the patient stabilized shortly thereafter.

Manufacturer Narrative

The navx study data was provided and reviewed.The reported event stated that ¿the catheters shifted multiple times¿.Review of the study was unable to confirm the shift, however the description of the event is consistent with a catheter display shift.Review of the ensite cardiac mapping system verifies that in some cases a catheter display shift can occur.If a shift occurs, it is recommended to use enguide alignment to return the catheters to their previous positions relative to the model.See ensite cardiac mapping system ifu, setup, enguide alignment.The cause of the reported heart block remains unknown.

Event Description

During a supraventricular tachycardia procedure with the use of conscious sedation, the patient experienced 2nd degree heart block during one of the cryo ablations with a non-abbott device.Three fixed curve catheters and one steerable decapolar catheter was placed inside the right atrium.Resp.Comp.Was applied and the catheters shifted multiple times.The heart block was transient in nature and the patient stabilized shortly thereafter.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• Type of Device: COMPUTER, 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.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13904665
• MDR Text Key: 287920533
• Report Number: 2184149-2022-00089
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8034536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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