MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ STOCKERT GENCONNECT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100036696

Device Problem High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

Related manufacturer ref#2184149-2022-00134.During an atrioventricular reciprocating tachycardia procedure, an impedance issue occurred causing a delay.When using ensite precision and the atakr genconnect, the connection was unsuccessful.The rf generator was replaced with a stockert and the impedance baseline was high in the left atrium.The impedance baseline was checked without the genconnect and the values were 100 ohms less.The genconnect was replaced and the issue was resolved.The procedure was completed without patient consequences.

Manufacturer Narrative

One ensite velocity¿ stockert genconnect was received into the lab for investigation.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.The returned product is manufactured specifically for use with the biosense webster radio frequency generator as the front panel label indicates.Functional testing performed verified circuit integrity on all channels during the evaluation period.Normal output amplitudes and impedance values were observed during functional testing.Based on the information provided to abbott and the investigation performed, the root cause of the reported event cannot be conclusively determined as no abnormalities were identified.The returned product operated as designed during the evaluation period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE VELOCITY¿ STOCKERT GENCONNECT
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14545447
• MDR Text Key: 300730006
• Report Number: 2184149-2022-00133
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100036696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ENSITE VELOCITY¿ ATAKR GENCONNECT KIT