MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H702496

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a supraventricular tachycardia ablation procedure, while performing a pace map, as the pacing site was changed, the catheter shifted.A shift occurred and the second tachycardia was abandoned.There were no adverse consequences to the patient.

Manufacturer Narrative

Though the intended svt procedure was completed, during additional mapping of noted pvc's the shift occurred.Per the instructions for use a shift can be minimized by positioning the system reference patch nearer to the patient¿s heart.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• 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: 8964307
• MDR Text Key: 156569165
• Report Number: 2184149-2019-00161
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H702496
• Device Catalogue Number: H702496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 85