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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LVAD VENTRICULAR (ASSIST) BYPASS

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MEDTRONIC, INC. MEDTRONIC LVAD VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problems Defective Device (2588); Battery Problem (2885); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 11/07/2017
Event Type  Injury  
Event Description
Was implanted with medtronic lvad in 2017 when problems were found with this model. It has cost me extra dr visits, tests and monitoring which has increased out of pocket expenses. Was not told of any problems till a propublica reported and interviewed me, and after that i was sent a letter. In 2020 had a controller failure which made me have a hospital stay just to replace the controller; 3 months later i received a 56,000. 00 bill for the replacement. Before installation i did think to ask about batteries and was told they would change out yearly. Recently i had a battery go bad and had to jump through hoops to get replaced. Medtronic bought the company that originally manufactured these in 2016 there about. I wonder if they were giving dr kickbacks to use on unsuspecting patients like myself, seeing that they had technicians at the hospital full time? fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC LVAD
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key14732109
MDR Text Key294408736
Report NumberMW5110372
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 06/16/2022 Patient Sequence Number: 1
Treatment
DIGOXIN.; MEDTRONIC DEFIBRILLATOR.; MEDTRONIC LVAD.; OMEGA 3.; PAROXETINE.; PROTONIC.; WARFARIN.
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