MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY? COOL FLEX? ABLATION CATHETER, UNKNOWN; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problems Dyspnea (1816); Nerve Damage (1979)

Event Date 02/27/2015

Event Type  Injury  

Event Description

Following a successful right atrial tachycardia ablation procedure, the patient was discharged home and on the following day's post op appointment, the patient complained of dyspnea.A phrenic nerve lesion was diagnosed.No performance issues were noted with any sjm devices used during the procedure.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the model and lot numbers were unavailable.Based on the information received, the cause of the reported phrenic nerve damage could not be conclusively determined.

• Brand Name: THERAPY? COOL FLEX? ABLATION CATHETER, UNKNOWN
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4667699
• MDR Text Key: 5731984
• Report Number: 2030404-2015-00026
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110016
• 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
• Report Date: 03/10/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IBI GENERATOR; ENSITE VELOCITY; COOL POINT PUMP
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 65