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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HARMONY DELIVERY CATHETER SYSTEM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

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MEDTRONIC HEART VALVES DIVISION HARMONY DELIVERY CATHETER SYSTEM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI Back to Search Results
Model Number HARMONY-DCS
Device Problems Use of Device Problem (1670); Activation, Positioning or SeparationProblem (2906); Difficult to Advance (2920)
Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)
Event Date 11/19/2021
Event Type  Injury  
Event Description
Medtronic received information that during the implant of this transcatheter pulmonary bioprosthetic valve, in a patient with an existing defibrillator, while placing the valve the atrial lead was dislodged and the atrium was perforated. The procedure was converted to a surgical procedure to stabilize the bleed. No additional adverse patient effects were reported.
 
Manufacturer Narrative
Product analysis: no product was returned.   conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameHARMONY DELIVERY CATHETER SYSTEM
Type of DevicePULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13006878
MDR Text Key284724213
Report Number2025587-2021-03748
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P200046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberHARMONY-DCS
Device Catalogue NumberHARMONY-DCS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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