MAUDE Adverse Event Report: CONMED HYFRECATOR OR ELECTROCAUTERY TREATMENT OF ANAL HSIL

Model Number 7-900-115

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Syncope (1610); Bradycardia (1751); Fall (1848); Tachycardia (2095)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2016 the participant experienced a pre-syncopal episode.The participant went to (b)(6) medical center ed after falling forward on his face.On (b)(6) 2016 the subject was seen by (b)(6) cardiology - dr.(b)(6).Ekg and tte ordered.Pt given a zio patch (event heart monitor) and told to wear it for 14 - 21 days.After 2 days the patch would no longer stick to his skin due to sweating.On (b)(6) 2016 pt was seen by dr.(b)(6) in cardiology as a new pt, for sinus pauses and tachy-brady on ziopatch.Diagnosis: sick sinus syndrome.On (b)(6) 2016 the subject went in for outpatient surgery for dual-chamber pacemaker implantation.Discharged same day.Additional details will be provided in an amendment.Start date of first course: (b)(6) 2016.Start date of course associated with expediated report: (b)(6) 2016.Start date of primary ae: (b)(6) 2016.End date of primary ae: (b)(6) 2016.

• Brand Name: HYFRECATOR OR ELECTROCAUTERY TREATMENT OF ANAL HSIL
• Type of Device: HYFRECATOR OR ELECTROCAUTERY TREATMENT OF ANAL HSIL
• Manufacturer (Section D): CONMED
• MDR Report Key: 6311469
• MDR Text Key: 66937328
• Report Number: MW5067734
• Device Sequence Number: 1
• Product Code: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: 7-900-115
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1