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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER
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MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER Back to Search Results
Model Number MC1VR01
Device Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the leadless implantable pulse generator (ipg) exhibited premature battery depletion prior to being implanted.This device was not used, and the procedure was successfully completed using a replacement device.No patient complications have been reported as a result of this event.
 
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Brand Name
MICRA
Type of Device
LEADLESS PACEMAKER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IE  
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9939648
MDR Text Key188119182
Report Number9612164-2020-01532
Device Sequence Number1
Product Code PNJ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P150033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2021
Device Model NumberMC1VR01
Device Catalogue NumberMC1VR01
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2020
Date Device Manufactured10/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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