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

Model Number CD3371-40QC

Device Problems Under-Sensing (1661); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Date 02/08/2019

Event Type  Death  

Event Description

It was reported that the patient was deceased due to episodes of ventricular fibrillation (vf) in which the device was unable to terminate the arrhythmia.Technical support was contacted and noted that there were four episodes of vf, three of which the device delivered anti-tachycardia pacing (atp) and shock therapy, but the device did not deliver a shock in the fourth episode.It was suggested by technical support that undersensing may have led to the vf not being detected because the patient¿s signal amplitudes were very low.The device behaved according to its programmed settings in each of the episodes and no malfunction was suspected.The device was explanted following the death.

Manufacturer Narrative

Upon receipt, the device was interrogated with a programmer and the device image was retrieved.The device¿s sensing, pacing, lead impedance, high voltage (hv) charging, hv delivery, and hv shock impedance were tested, and the device¿s function was normal.The device had not reached elective replacement indicator (eri) or end of service (eos).A visual inspection was performed, and bodily fluids were observed in the header, no other anomalies were observed.The device session records were reviewed by technical services.The device behavior was found to be normal and the device behaved according to its programmed settings.The reported event of intermittent undersensing and inhibition of high voltage output was not confirmed.The loss of therapy was due to low signal amplitudes.

• Brand Name: QUADRA ASSURA MP 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8360065
• MDR Text Key: 136837572
• Report Number: 2938836-2019-01209
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 06/27/2019

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: 02/29/2020
• Device Model Number: CD3371-40QC
• Device Catalogue Number: CD3371-40QC
• Device Lot Number: P000057122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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