MAUDE Adverse Event Report: ST. JUDE MEDICAL FIRMAP¿ CATHETER 50MM, US EDM; ELECTRODE RECORDING CATHETER

Model Number AR064050

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

Patient Problem Paralysis (1997)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported diaphragmatic right paralysis was procedure related.

Event Description

During the (b)(6) study, diaphragmatic right paralysis occurred.X-ray was to be repeated in approximately 3 months.There was no malfunction of the device reported and no additional information is available.(b)(6) study, clinical study patient id: (b)(6).

• Brand Name: FIRMAP¿ CATHETER 50MM, US EDM
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8925315
• MDR Text Key: 155343876
• Report Number: 3005334138-2019-00456
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130827
• 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: 08/23/2019

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: AR064050
• Device Catalogue Number: AR064050
• Device Lot Number: TPR041117
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 98