MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE PACEMAKER/DEFIBRILLATOR

Model Number CD-33557-40

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Loss of consciousness (2418); Electric Shock (2554)

Event Date 12/19/2014

Event Type  Injury  

Event Description

Four days post-implantation of pacemaker-defibrillator to replace recalled device, was choking on ice & lifted both arms to breathe when was jolted backwards with glasses flying off & few sec's of blackout.

• Brand Name: ST. JUDE PACEMAKER/DEFIBRILLATOR
• Type of Device: ST. JUDE PACEMAKER/DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 4946023
• MDR Text Key: 6039348
• Report Number: MW5044824
• Device Sequence Number: 1
• Product Code: NIK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: CD-33557-40
• Patient Sequence Number: 1
• Treatment: SPIRONOLACTONE 25MG; QUNOL MEGA CQ10 100MG; TRADER JOE'S MULTIVITAMIN; CARVEDILOL 25MG; XARELTO 20MG; DHEA 25MG; AMLODIPINE 10MG; LOSARTAM POTASSIUM 100MG
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Weight: 107