MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); DEFIBRILLATION LEAD

Model Number LEAD

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/28/2021

Event Type  Death  

Manufacturer Narrative

Appropriate clinical signs, symptoms, conditions term / code not available - " anoxic brain injury, coma".Note: information was received via a medwatch form mw5103693.Abbott serial and model number was not listed on the medwatch form only a non abbott manufacturer.Further information was requested from the initial reported but not received.

Event Description

It was reported that the patient's non abbott cardioverter defibrillator failed while at home.The lead (unknown if this is an abbott or non abbott product) failed six times to supply sufficient voltage for defibrillation.The patient experienced cardiac arrest, anoxic brain injury, coma and comfort measures were taken.The patient passed away shortly after.Interrogation showed normal lead function (unconfirmed manufacturer) in terms of impedance, sensing and capture thresholds.However the device failed to deliver adequate energy needed for successful defibrillation.In discussions with the manufacturer (unconfirmed if abbott or non abbot product) the issue appeared to be consistent with a right ventricular (rv) lead malfunction.Note: information was received via medwatch form mw5103693.

• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12602670
• MDR Text Key: 275855521
• Report Number: 2017865-2021-32966
• 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: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021,10/10/2021

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: Health Professional
• Device Model Number: LEAD
• 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: 09/02/2021
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention