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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 500DM29
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Arrhythmia (1721)
Date of Event 08/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
Medtronic received information that during the hospital stay, post implant of this mitral mechanical valve, the patient developed a junctional rhythm which was treated with the implant of a permanent pacemaker.No additional adverse patient effects were reported. .
 
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Brand Name
OPEN PIVOT MECHANICAL HEART VALVE
Common Device Name
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
MEDTRONIC, INC.
3800 annapolis lane
minneapolis MN 55447
MDR Report Key7951852
Report Number3008592544-2018-00044
Device Sequence Number1190078
Product Code LWQ
UDI-Device Identifier00643169335066
UDI-Public00643169335066
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P990046
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/21/2021
Device Model Number500DM29
Device Catalogue Number500DM29
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/14/2018
Initial Report FDA Received Date10/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
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