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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC IMPLANTABLE CARDIAC PACEMAKER IMPLANTABLE, PACEMAKER, PULSE-GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Death (1802); Loss of consciousness (2418)
Event Date 02/11/2019
Event Type  Death  
Event Description
On (b)(6) 2019 patient (my grandmother) underwent a pacemaker implant surgery at (b)(6). The surgery was completed and patient was to be discharged the following day. We had requested medtronic pulse generator. On (b)(6) 2019, physicians suggested another day to observe status of patient due to unrelated kidney issues. On (b)(6) 2019, patient was feeling fine upon being spoken to by family, however became unconscious and experienced syncope immediately after symptoms of feeling uneasy. Emergency cpr was performed to revive patient, and further tests and scans were run to regain patient's consciousness. The patient unfortunately passed away around 10pm on (b)(6) 2019. Please analyze and evaluate detailed report as to the issues and what caused the death of the patient.
 
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Brand NameIMPLANTABLE CARDIAC PACEMAKER
Type of DeviceIMPLANTABLE, PACEMAKER, PULSE-GENERATOR
Manufacturer (Section D)
MEDTRONIC, INC
MDR Report Key8362509
MDR Text Key136911747
Report NumberMW5084217
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 Patient Family Member or Friend
Type of Report Initial
Report Date 02/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 02/21/2019 Patient Sequence Number: 1
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