MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL ATRIAL LEAD; PERMANENT PACEMAKER ELECTRODE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219); Coma (2417)

Event Date 08/28/2021

Event Type  Death  

Event Description

Patient's cardio defibrillator malfunctioned while at home.The lead failed 6 times to supply sufficient voltage for defibrillation.Patient experienced cardiac arrest, anoxic brain injury, coma and was made comfort measures only.Patient passed away shortly after.Interrogation shows normal lead function in terms of impedance, sensing and capture thresholds.However, device failed to deliver adequate energy needed for successful defibrillation.In discussion with device manufacturer representatives, this appears to be consistent with a rv lead malfunction.Cxr does not reveal any evidence of lead malposition or fracture.Fda safety report id # (b)(4).

• Brand Name: ATRIAL LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT MEDICAL
• MDR Report Key: 12421262
• MDR Text Key: 270063465
• Report Number: MW5103693
• Device Sequence Number: 2
• Product Code: DTB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/31/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• 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): Death
• Patient Age: 64 YR
• Patient Weight: 60