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

Model Number H702496

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

The ensite cardiac mapping system display workstation configuration parameters were reviewed.The behavior described is consistent with expected behavior of the system during heavy computation, which may be caused by a full computer hard drive.The exact cause for the reported event remains unknown.

Event Description

During an ablation procedure, the system froze several times during the procedure.The procedure was cancelled with no adverse patient consequences.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-ST. PAUL); 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: 8167551
• MDR Text Key: 130459426
• Report Number: 2184149-2018-00199
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2018

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: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/15/2018
• 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