MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problem Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 12/08/2020

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.  based on the information received, the cause of the reported incident could not be conclusively determined.However, the healthcare professional stated the patient's death was due to the patient's condition, and not a malfunction of the abbott product.

Event Description

The patient passed away due to ventricular fibrillation (vf).The transmission on merlin.Net was reviewed showing eight non-sustained vf/ventricular tachycardia (vt) episodes.The egm showed an irregular rhythm with ventricular complexes with varying amplitudes consistent with a dying heart.Due to the autosense feature, intermittent undersensing was observed.The vf episode was detected, anti-tachycardia pacing was delivered; however, charging for defibrillation was aborted due to return to sinus.The undersensing present may have led to premature return to sinus.The healthcare professional did not allege a malfunction of the icd rather the event occurred due to the patient's condition.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11013641
• MDR Text Key: 221706364
• Report Number: 2938836-2020-09672
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: CD3361-40C
• Device Lot Number: S000057485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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