MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ST JUDE (PULSE GENERATOR AND RV LEAD); AICD

Model Number CD411-36Q

Device Problem Device Sensing Problem (2917)

Patient Problems Cardiac Arrest (1762); Death (1802); Renal Failure (2041); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 10/15/2018

Event Type  Injury  

Event Description

The pt had a cardiac arrest at home with prolonged downtime, was resuscitated by ems and brought to the hosp in critical condition.Evaluation of the aicd revealed that it had malfunctioned and was only capturing r wave progression at 0.8 mv.Pt passed away (b)(6) 2018.The pt had multiple underlying conditions on arrival including significant lactic acidosis, metabolic derangements, transaminitis and renal failure.

• Brand Name: ST JUDE (PULSE GENERATOR AND RV LEAD)
• Type of Device: AICD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. ; st. paul MN
• MDR Report Key: 8027638
• MDR Text Key: 125916330
• Report Number: 8027638
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CD411-36Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2018
• Distributor Facility Aware Date: 10/19/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2018
• 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: 47 YR
• Patient Weight: 85