MAUDE Adverse Event Report: SAINT JUDE'S/ABBOTT MEDICAL 3369-40Q QUADRA ASSURA MP; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 33-40Q QUADRA ASSURA MP

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2019

Event Type  Injury  

Event Description

As i was in recovery the defibrillator went off 27 times straight, i was rushed to icu where i was knocked out by drugs, i was told by nurses that i died twice while they were trying to figure out what to do.They have adjusted the pacemaker/defibrillator to a setting that makes it extremely hard to set off, this adds to my vulnerability of dying from a heart attack.Fda safety report id# (b)(4).

• Brand Name: 3369-40Q QUADRA ASSURA MP
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): SAINT JUDE'S/ABBOTT MEDICAL
• MDR Report Key: 12985511
• MDR Text Key: 282297042
• Report Number: MW5105993
• Device Sequence Number: 1
• Product Code: NIK
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33-40Q QUADRA ASSURA MP
• Device Lot Number: 40Q
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL AS NEEDED ; AMIODARONE HCL - 200 X 2 ; BUDESONIDE 10MG/10ML SUP X 2 ; CITRUCEL 500 2X2 ; D 3 25MCG (1000 IS) ONCE A WEEK ; DECONGESTANT; DOXYCYCLINE HYCLATE. 100MG X 2 ; ELOQUIS 5MG X 2; ESCITALAPRAM 10MG; IRON. 65MG X 1 ; LISINOPRIL 5MG X 1 ; LORAZEPAM- AS NEEDED ; METFORMIN 500 2X2 ; METOPROLOL 25MG X 1 ; METRONIDAZOLE 250MG X 4 ; MEXILETINE - 150MG X 2 ; OLANZAPINE 20MG ; OMEPRAZOLE 40MG X 1 ; PAROXETINE 40MG X 1 ; SIMVASTATIN 40MG X 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White