MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3367-40C

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661); Decreased Sensitivity (2534)

Patient Problems Heart Failure (2206); Shock from Patient Lead(s) (3162)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient presented to the emergency room with heart failure and intermittent undersensing on a ventricular channel resulting in delayed hv therapy.The patient received multiple shocks while traveling abroad, but was not aware of it.Programming changes were made at that time.Review of the egm's revealed that the undersensing did not start until apt was delivered and caused the rhythm to degenerate, resulting in small far-field signals and increased variability of r-waves in the near field channel.Last episode successfully converted the rhythm.Recommended programming changes were made.The patient was stable.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6353350
• MDR Text Key: 68153906
• Report Number: 2938836-2017-16129
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2017

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 Expiration Date: 01/31/2016
• Device Model Number: CD3367-40C
• Device Lot Number: 4455427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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): Required Intervention