MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number H702496

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

During a comprehensive electrophysiology study with arrhythmia induction, the slave image froze.By changing screens the image would become live for thirty seconds and then freeze again.The case was continued by resetting the screen every time it froze.The case was completed however, there was some delay in the procedure time.There were no adverse consequences to the patient.

Manufacturer Narrative

Review of the case study logs did not reveal any software issues and there were no error messages correlating to the non-abbott remote monitor.Further information indicated that the site had adjusted the remote monitor configuration in attempts to work with non-abbott display hardware.Further communication with the customer revealed the issue was resolved the following day by the altering the resolution setting on the remote monitor.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING 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: 7004232
• MDR Text Key: 91516074
• Report Number: 2184149-2017-00048
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• 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
• Patient Age: 68 YR
• Patient Weight: 97