MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE PRECISION¿ POWER CABLE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100143451

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

Prior to a procedure it was noted that the connecting hub of the cable was broken and sparked when plugged in.There were no adverse patient or user consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported sparks could not be determined.The receiving inspection records were reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with manufacturing specifications and procedures.

• Brand Name: ENSITE PRECISION¿ POWER CABLE
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7992716
• MDR Text Key: 124692919
• Report Number: 2184149-2018-00172
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K172396
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100143451
• Device Catalogue Number: 100143451
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1