MAUDE Adverse Event Report: ST. JUDE MEDICAL. PUERTO RICO, LLC CRT-D UNIFY QUADRA; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC

Model Number CD3249-40Q

Device Problems Nonstandard Device (1420); Vibration (1674); Therapeutic or Diagnostic Output Failure (3023); Unintended Movement (3026)

Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 07/25/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 had an incident involving my crt-d implantable device for my heart it went off the morning of the (b)(6) buzzing and vibrating something i've never experienced before.Later that evening it went off again and i started noticing weird symptoms associated with the area of my left side where my device is located (real soreness, aching pain, and some swelling) i got scared and went to nearest er after explaining to them what had happened and they done a couple of tests they said they would have to transport me to another hospital that could deal with it.They tried reaching my dr and tried hard to get a transfer to a hospital he was affiliated with but got no answer back(difficult because of covid 19 situation).They finally found a hospital that would take me that could care for me.I was informed from the first hospital that it was a medical emergency that i got treatment right away.I didn't get to that hospital until in the early morning hrs on the (b)(6) was admitted and went through all the tests and agony for them to tell me later on that day that my crt-d was dead, and that it died on the (b)(6), they then informed me that it needed to be taken out right away and a new one put in asap.I was dead set on my dr doing it but with the dire situation at hand they said it would be dangerous for me to wait that long for a transfer that might come too late.I proceeded to let the dr they had there that i did not know do the procedure.I explained to the dr before the surgery that my other dr had already made a special pocket for the crt-d hiding it in my breast muscle (easy and simple).Well i guess the dr wanted to do things his way so by the time i got out of surgery and the medicine wore off; i knew i was in big trouble.The pain was and is unbearable he basically butchered me.Instead of him opening up the same incision and just popping old one out and popping new one on and placing it right back in the pocket my dr made for it, he decides he is going to make a brand new incision right below my collar bone.I'm not sure how he got old one out cause there is one incision, but i woke up during surgery cause i fell asleep for a minute, and i could feel the rough pressure and see his hands over the sheet stuffing something in that area not sure if it was the device or what he was shoving.So long story shortened i had muscle, nerves, tendons and whatever else that's in that area permanently damaged.There is even something wrong with my neck as well cause when i turn my head i can feel a pulling pain.I had no fat in that area to even put a device in and to be blunt my boobs are now lop-sided and crooked when they wasn't before, not sure if i will make it through this that's why i wanted to write this to you and see if there is anyway you could help me or give me advice on what to do? the hospital told me that i had a recalled crt-d device.My device was a st jude crt-d model # cd3249-40q.Fda safety report id # (b)(4).

• Brand Name: CRT-D UNIFY QUADRA
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC
• Manufacturer (Section D): ST. JUDE MEDICAL. PUERTO RICO, LLC
• MDR Report Key: 10367184
• MDR Text Key: 202039602
• Report Number: MW5095884
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/30/2021
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 72