MAUDE Adverse Event Report: PROLIEVE; MICROWAVE

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Pain (1994)

Event Date 08/05/2014

Event Type  Death  

Event Description

My husband, (b)(6), received in-office treatment for enlarged prostate using the prolieve system (microwave treatment).His urologist was (b)(6).He died 10 days after the procedure, in spite of 2 trips to (b)(6) hospital emergency department ((b)(6)) and numerous visits for follow-up with dr.(b)(6).He was in constant pain and unable to urinate normally after the procedure and until his death.No exploratory measures were taken to determine the cause of his pain and difficulties prior to this death; the only treatment he received was numerous insertion and removal of catheters, even though he continuously complained of great pain.We did inform the hospital of his history of a pulmonary embolism precipitated by dvt after an airline flight about 8 years prior; unsure of any connection/significance.He died at home the morning of (b)(6) just after awakening and calling out for help.He was not breathing and the emts were unable to revive him.He was taken to (b)(6) hospital (arrived unresponsive).An autopsy was not performed as i was told it would cost (b)(6) and is not covered by insurance.His death certificate lists immediate cause of death as cardiopulmonary respiratory arrest, underlying cause cardiovascular disease, although i am 100% certain his death was directly attributable to the prolieve procedure/treatment he received on (b)(6).Prior to that procedure he displayed no associated symptoms of pain or illness other than the common urological issues associated with bph.

• Brand Name: PROLIEVE
• Type of Device: MICROWAVE
• MDR Report Key: 4181882
• MDR Text Key: 5093567
• Report Number: MW5038606
• Device Sequence Number: 1
• Product Code: MEQ
• 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
• Report Date: 10/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 130