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

Model Number CD3371-40QC

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

Patient Problems Muscle Stimulation (1412); Arrhythmia (1721); Therapeutic Effects, Unexpected (2099)

Event Date 07/03/2019

Event Type  Injury  

Event Description

It was reported that a patient presented in clinic with diaphragmatic stimulation.Upon interrogation of the patient's implantable cardioverter defibrillator, it was found to be in backup vvi (bvvi) mode.Review of past electrograms show that the device had delivered therapy multiple times.The device was explanted and replaced.Patient was stable.

Event Description

It was reported that a patient presented in clinic with diaphragmatic stimulation.Upon interrogation of the patient's implantable cardioverter defibrillator, it was found to be in backup vvi (bvvi) mode.Review of past electrograms show that the device had delivered therapy multiple times therapies and it was not known if they were adequate.Therapies were turned off for several days and required a long hospitalization in intensive care while a medical decision was being made on whether or not to restart the software.The device was explanted and replaced.Patient was stable.

Manufacturer Narrative

The reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a power on reset (por).The device was tested on the bench and arc marks and lead material was noted on the device can.The cause of the bvvi was consistent with lead arcing to the device can.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8799164
• MDR Text Key: 151329880
• Report Number: 2017865-2019-11060
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: CD3371-40QC
• Device Lot Number: S000031100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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): Hospitalization; Other; Required Intervention