MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD QUADRA ASSURA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40Q

Device Problems High impedance (1291); Over-Sensing (1438); Decreased Sensitivity (2534)

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

Event Date 07/30/2014

Event Type  Injury  

Event Description

It was reported that high, out of range, pacing impedance, noise, decreased r-wave amplitudes, and increased capture thresholds were observed during a clinical follow-up.The lead tested normal and the anomalous measurements were noted only when connected to the device.The device was explanted and replaced.All measurements were normal with the new device.No further issues have been reported.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).Evaluation description included.The reported field event of sensing and capture anomaly could not be confirmed in the laboratory.The reported field event of high, out of range pacing lead impedance was confirmed in the laboratory via programmer printouts.The device was tested on the bench and using automated testing equipment, and no anomalies were found.The cause of the high pacing lead impedance could not be determined.

• Brand Name: QUADRA ASSURA CRT-D, DF-4 CONNECTOR
• 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: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4204833
• MDR Text Key: 15997140
• Report Number: 2938836-2014-17114
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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: 04/30/2016
• Device Model Number: CD3365-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2014
• Initial Date FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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
• Patient Age: 62 YR