MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; INTRODUCER, CATHETER

Model Number I DO NOT HAVE

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Cardiac Tamponade (2226); Coma (2417)

Event Date 02/14/2022

Event Type  Injury  

Event Description

The heart was perforated; i had pericardial tamponade and went into a coma, requiring intubation.In icu and intubated about a week.Medtronic micra.Attaching more info.Fda safety report id # (b)(4).

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 14169810
• MDR Text Key: 289906881
• Report Number: MW5109236
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I DO NOT HAVE
• Device Catalogue Number: ASK THE DOCTOR
• Device Lot Number: ASK DOCTOR
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: EZETEMIDE ; FISH OIL; KLONOPIN ; MELATONIN ; MIDODRINE; PRALUENT; VIT D3K2
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White