MAUDE Adverse Event Report: PACEMAKER

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Align (2522)

Patient Problems Weight Changes (2607); Lymphoma (3263)

Event Type  Injury  

Event Description

Pearl sack in front of heart and lung was fluid with 1 liter of fluid.Had to be drained every 10 to 15 days for some time.Text back in 4 days "non hodgkins lymphoma.Pearl sack in front of heart and lung was fluid with 1 liter of fluid.Doctor drained on friday sent to (b)(6).Tuesday doctor called husband that the fluid was non-hodgkins lymphoid.It was from the product "enbrel", had to start chemotherapy immediately or death in 8 months at most.He is not a quitter and knows the lord and now it is 2 years gone.But he has been to living hell and back.He has lost 75 pounds, falls, is now a bleeder, no appetite and consumes very little food.I am getting him a very good diet here in (b)(6) trying to build his body, immune system back up, massages.Try to get his muscles built back up.His blood and immune system.He has lost 75 pounds.He use to bench press 500 pounds.Biceps were 22 inches.He is 6 foot 3 inches and big body frame.Now all muscles are sagging, weak, very tired, not much strength.Bless his heart.He has had 4 or 5 time of overcoming the cancer.He is within hospice in (b)(6).But would like to do away with hospices.Pray for him.If he does, pass.Implants, such as breast implants, pacemakers, or catheters sometimes gets out of alignment.(b)(6).First problem - doctors forgot to set a button correctly.(b)(6) corrected it and apologized to (b)(6) their error.Implant was not sure a little before, (b)(6) 2013.Due to chemo therapy, damaged heart 3 valves closed, 1 valve leaking.Pacemaker installed "non hodgkins lymphoma.

• Brand Name: PACEMAKER
• Type of Device: PACEMAKER
• MDR Report Key: 4834980
• MDR Text Key: 17309271
• Report Number: MW5043028
• Device Sequence Number: 1
• Product Code: DRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ENBREL 1 SHOT WEEKLY BY INJECTIONS FOR PSORIASIS; (TX DATE: 06/2011 TO 06/2013)
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 64 YR
• Patient Weight: 82