MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3265-40

Device Problems Defibrillation/Stimulation Problem (1573); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2013

Event Type  malfunction  

Event Description

It was reported that during a device upgrade, dft testing failed to convert the patients arrhythmia.External defibrillation was successfully performed to convert the patient back to sinus rhythm.Possible output circuit damage was suspected, and low high voltage lead impedance was also noted.The device and lead were replaced and patient experienced no complications.

Manufacturer Narrative

The reported field events of lead impedance and output anomalies were confirmed via review of the device image.It was noted that there were two aborted charges due to an over-current detection.The device was tested on the bench as well as using automated test equipment and no anomalies were found.The cause of the field events could not be determined.

• Brand Name: QUADRA ASSURA CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 3560139
• MDR Text Key: 4056117
• Report Number: 2938836-2014-00636
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: CD3265-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/09/2013
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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
• Treatment: 7001/65, (B)(4)
• Patient Age: 69 YR