MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VALLEYLAB INDIFFERENT GROUNDING PAD; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 85722

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

During an ablation procedure, a patient burn occurred on the back of the patient.

Manufacturer Narrative

Additional information confirmed the device involved in the event was a valleylab patch (e7506) and not the ensite navx patch reported on the initial report.After further information regarding this event was received, the indifferent grounding pad (valleylab, e7506) was found to be manufactured by (b)(4) and reporting of this event will be submitted by covidien.

Event Description

During an ablation procedure, a patient burn occurred on the back of the patient.

• Brand Name: VALLEYLAB INDIFFERENT GROUNDING PAD
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6475492
• MDR Text Key: 72213110
• Report Number: 2184149-2017-00004
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 05/01/2017

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: 85722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• 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
• Patient Outcome(s): Other