MAUDE Adverse Event Report: PHILLIPS/COFFEY MEDICAL HOLTER MONITOR; PHILLIPS HOLTER MONITOR

Device Problems Electrical Shorting (2926); No Fail-Safe Mechanism (2990)

Patient Problems Pain (1994); Scarring (2061); Impaired Healing (2378); Partial thickness (Second Degree) Burn (2694)

Event Date 01/18/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, my healthcare provider, (b)(6) attached a phillips holter monitor (serial # (b)(4)) using covidien/medtronic electrodes (530 series) on me for 24 hours cardiac monitoring.I was injured, receiving second degree electrical burns from one lead placed in the center of my chest.This burn caused unbearable pain, slow healing, an increased risk for skin cancer, and a large, permanent scar that is quite noticeable.I was hoping time and laser surgery would help.It has not, i reached out to (b)(6), phillips, and medtronic/covidien and asked how their products severely burned me, how often others have sustained similar injuries, why no warnings of burning had been issued, and most importantly, if they now plan to issue warnings of burning for future users of their said products.Unfortunately, i have received no explanation from any of them.None have taken responsibility for my unfortunate injury.I hope your investigation can bring me the answers i have been seeking.Explaining my burn is important to prevent future problems for me and also to make sure nobody else is injured.Please let me know if you need more info.I have photos, medical reports, and the electrodes that were used that still contain my burnt skin.The bottom line is, i was severely burned in the center of my chest while attached to a phillips holter monitor (installed by (b)(6)), using medtronic electrodes, through no fault of my own.The 24 hour cardiac readings showed zero abnormal readings and product was returned a few minutes after test was completed.That is when i discovered burn and sought immediate treatment.Thank you for protecting the public health.I believe that the mfrs who produced and sold the products that generated enough heat over a 24 hour period, to cause 2nd degree electrical burns, should be required to warn their customers when heat is defectively being produced.It was unk to me that i was being burned over that 24 hr period.When electrode was removed, the pain was unbearable and the burn was seen.The cardiac monitoring recorded the whole time not indicating any problems.At the very least, the products should either shut off when they are burning somebody or an alarm should be sounded that heat is being generated defectively.Phillips/(b)(4) medical holter monitor, covidien/medtronic electrodes.Second degree electrical burn from holter monitor.

Event Description

Add'l info received from reporter for mw5073047 on 01/17/2018.I thought it was important to send a f/u report to help your scientific staff understand my injury more clearly.I have included some pictures of my injury (with dates) and also the initial dr report and also my last appt with dermatologist.I hope this helps.I also had a few questions regarding the maude and mdr database search.I notified philips, (b)(4), and covidien / medtronic regarding my injury last year, but i am unable to find any info regarding my injury on these data bases.I am not quite sure what i am doing wrong to locate this info.Any help would be appreciated.I think my info is important to inform others.I have many f/u medical appts and also more pictures if needed.Thank you.

Event Description

Add'l info received from reporter on 09/12/2018 for mw5073047: i was wearing a 24 hour holter monitor for diagnostic purposes and received 2nd degree burns.I want to know how and why this happened.It was suggested by my grandson (age 14) that it would be beneficial if i could send you close up photos of the covidien/medtronic 530 series electrode that obviously shorted out, causing a second degree electrical burn in the center of my chest.He said that the photos i had previously sent, may not be as easy to spot or see, where the electrical short on the electrode actually happened.I agreed.So i hope these enlarged photos help in the fda's assessment as to what went wrong resulting in my unfortunate incident (2nd degree burn) while wearing a 24 hour philips holter monitor using medtronic electrodes attached by (b)(6).As i have previously told you, i have the electrode that were attached to me that day.Please let me know if having them tested would somehow help your assessment or if sending them to you would help.I think it is obvious which electrode caused the burn.You can see the short/burn in the electrode photo and also my blood on the other side of the electrode.Thank you for your help.I look forward to hearing from you.

• Brand Name: HOLTER MONITOR
• Type of Device: PHILLIPS HOLTER MONITOR
• Manufacturer (Section D): PHILLIPS/COFFEY MEDICAL
• MDR Report Key: 6989965
• MDR Text Key: 90785252
• Report Number: MW5073047
• Device Sequence Number: 0
• Product Code: MLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 70