MAUDE Adverse Event Report: ST. JUDE MEDICAL MAPPING, VISUALIZATION, AND NAVIGATION DEVICE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-R-AMP-01

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

Patient Problem Stroke/CVA (1770)

Event Date 08/25/2022

Event Type  Injury  

Event Description

Patient's son informed site that patient has been hospitalized in an external hospital due to multiple cerebral infarcts.Patient discharged from site on (b)(6) 2022 after ablation procedure which had been performed on (b)(6) 2022.Hospitalization externally due to stroke in the night of (b)(6) 2022.Patient suffered from repeat infarcts during the hospitalization.Finally patient was transferred to geriatrics.Investigator does not assess event as obviously procedure-related, but only possibly related: occurence after > 48 hours, the inr was in a therapeutical range, act during ablation was rather high.Patient had an extremely dilated la with slightly decreased flow in laa.Differential diagnosis stenosis of aci.After an ablation procedure, the patient experienced multiple cerebral infarcts requiring hospitalization.The patient was discharged 2 days post procedure, and the next day the patient experienced a stroke.Multiple infarcts were noted in the patient during hospitalization.It is not confirmed whether the side-effects were procedure related or not.The inr was in a therapeutical range, act during ablation was high, and the patient had a dilated la with decreased flow in the laa.There was also a differential diagnosis of stenosis of aci.

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 determined.

Event Description

Further information received confirmed the serial number provided is not the correct serial number for the complaint device.The serial number or the complaint device is unknown.

• Brand Name: MAPPING, VISUALIZATION, AND NAVIGATION DEVICE
• 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: 15811968
• MDR Text Key: 303800491
• Report Number: 2184149-2022-00273
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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: ENSITE-R-AMP-01
• Device Catalogue Number: ENSITE-R-AMP-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 11/29/2022
• 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): Hospitalization