MAUDE Adverse Event Report: CARDIAC PACEMAKER; HEART PACEMAKER

Model Number 23-265-8963

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Confusion/ Disorientation (2553); Lethargy (2560)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Onset began on (b)(6) 2018 while at home pt became confused and could not remember where she was or form words.Pt then became lethargic and incoherent.Ambulance was called and was determined that pt had suffered a possible stroke.Pt was taken to (b)(6) for further evaluation.Dates of use: (b)(6) 2018.Diagnosis or reason for use: artificial heart valve.

• Brand Name: CARDIAC PACEMAKER
• Type of Device: HEART PACEMAKER
• MDR Report Key: 7251081
• MDR Text Key: 99564449
• Report Number: MW5075132
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 23-265-8963
• Device Catalogue Number: 23-265-8963
• Device Lot Number: 223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR
• Patient Weight: 103