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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA; LEADLESS PACEMAKER
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MEDTRONIC, INC. MICRA; LEADLESS PACEMAKER Back to Search Results
Model Number MC1VR01
Device Problems Battery Problem (2885); Capturing Problem (2891)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
It was reported that during use of lead less implantable pulse generator (ipg) initial threshold was high and exhibited tendency to rise, and threshold was unstable jumping up and down.Subsequently, the lead less ipg was explanted due to battery depletion after 14 months.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, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6322605
MDR Text Key67138260
Report Number2182208-2017-00327
Device Sequence Number1
Product Code PNJ
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P150033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 11/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMC1VR01
Device Catalogue NumberMC1VR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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