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

Model Number 100014514

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  Injury  

Event Description

During an ablation procedure, the amplifier would not function beyond the self test and the procedure was cancelled.Troubleshooting with the power cord, power outlet and air filter were performed, with no resolution.

Event Description

There were no adverse patient consequences due to the cancellation.

Manufacturer Narrative

Additional information: no product was returned for investigation. the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott, the reported cancellation could not be confirmed.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8422666
• MDR Text Key: 138852627
• Report Number: 2184149-2019-00026
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: 05414734210713
• Combination Product (y/n): N
• PMA/PMN Number: K141050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 100014514
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other