MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY CARDIAC MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number EE3000

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

One ensite velocity¿ system velocity amplifier was received into the lab for analysis.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Power was applied to the returned amplifier which successfully completed the post (power on self-test) and the system status light changed to green.System log files form the reported event date of (b)(6) 2020 were reviewed which revealed random qbs errors for the catheter amplifier boards in slots 4, 7 and 9.A full functional test was performed during the evaluation period and no faults, errors or changes in system status were observed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event could not be conclusively determined as no abnormalities were identified.

Event Description

During an afl ablation procedure, after using the amplifier for 1.5 hours, an amplifier error appeared on the ensite.While troubleshooting, it was noticed that the amplifier was flashing amber.After power cycling the amplifier twice, the light was solid amber.The procedure was aborted due to the reported issue.There were no adverse patient consequences.The patient is in stable condition.

• Brand Name: ENSITE VELOCITY CARDIAC MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10899940
• MDR Text Key: 218192261
• Report Number: 2184149-2020-00194
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: 100014514
• Device Lot Number: 6359758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• 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: 47 YR
• Patient Weight: 48