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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PACEMAKER, IMPLANTABLE PULSE GENERATOR

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MEDTRONIC, INC. PACEMAKER, IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number AZURE W1DR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fainting (1847); Fatigue (1849); Respiratory Distress (2045); Dizziness (2194)
Event Type  Injury  
Event Description
Pt experiencing lightheadedness, dizziness, shortness of breath, and severe fatigue.
 
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Brand NamePACEMAKER, IMPLANTABLE PULSE GENERATOR
Type of DevicePACEMAKER, IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key8624809
MDR Text Key145757158
Report NumberMW5086767
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberAZURE W1DR01
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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