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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/16/2019

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Approximately 4-5 weeks after an ablation procedure the patient was found to have an oesophageal fistula and passed away.There were no performance issues with any abbott device.Further information has been requested.

Event Description

On (b)(6) 2019, approximately 4-5 weeks after an ablation procedure, the patient was found to have an esophageal fistula and passed away.The patient had not been feeling well for several days prior and presented with stroke like symptoms, including right hemiparesis.A ct scan was performed, confirming the fistula.The patient was transferred to another hospital for surgical repair, but the patient continued to have neurological deterioration and surgery was not performed.The patient died on (b)(6) 2019.

• Brand Name: ENSITE¿ SYSTEM NAVX PATCH
• 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: 9340452
• MDR Text Key: 166939192
• Report Number: 2184149-2019-00230
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160186
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 118