MAUDE Adverse Event Report: MEDTRONIC, INC. CRT PACEMAKER; PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION

Model Number W1TRO1

Device Problems Premature Discharge of Battery (1057); Nonstandard Device (1420); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 06/18/2019

Event Type  Injury  

Event Description

Open heart surgery on (b)(6) 2019, tricuspid replacement, mitral vale repair; pfo closure, maze procedure, pacemaker changeout with epicardial leads placed at (b)(6) clinic.Returned to (b)(6) and 4 weeks later, recognized rapid battery depletion and right epicardial lead not working.Battery life went down to 2 years in 4 weeks.Symptoms on (b)(6) 2019 at insight prompted me to research info on computer.During research, found the fda warning about rapid depletion.Printed out info and brought to md highlighted since i am dependent pt for survival.No one at (b)(6) or medtronic ever notified me that this pacemaker was in the recall list.I am schedule to have surgery this wednesday (b)(6) 2019 to changeout device.During discussion with rep, medtronic will only reimburse me (b)(6) because i want a boston scientific placed.I've had pacemakers since i was 22 months old and this is the second time this has happened to me.The rep informed me that because i'm going with the competitor that's all the reimbursement i will receive, but that if i go with a medtronic they will reimburse me 100%.So 9 weeks post op, open heart surgery and now i will have a changeout and medtronic will do nothing for me.What about the pain and suffering i am about to endure again and the fact that no one had the decency to even notify me.Being a nurse myself i do my research thankfully.This is a multi billion dollar corporation and i am only dollar signs to them at this point.This seems completely unethical in every aspect of it.And the fact that people are out their dependent on these pacemakers for survival and are not even aware their device could be recalled is disgusting.This could be your mother, father or child and no one has the decency to set up and make it right.This to me is outrageous and inhumane.Unfortunately our society has come down to dollar signs and not people's lives.I have a beautiful family and grandchildren i am fighting to stay alive for, and you would think others would care about that as well.Shame on medtronic.This is disgusting.Fda safety report id# (b)(4).

• Brand Name: CRT PACEMAKER
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8739714
• MDR Text Key: 149669808
• Report Number: MW5087651
• Device Sequence Number: 1
• Product Code: NKE
• 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: 06/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: W1TRO1
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 66