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

Model Number CD3231-40Q

Device Problem Failure to Interrogate (1332)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)

Event Date 10/29/2014

Event Type  Injury  

Event Description

New information received notes that prior to replacement of the device the patient experienced dyspnea.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The reported field event of an inability to interrogate the device was confirmed in the laboratory and was due to premature battery depletion.Based on all available parameter and usage information, device longevity was found to be below the expected limits.With an external power supply attached, the device functioned normally.No high current was detected during testing and the power consumption was normal.The original battery was returned to the vendor for further evaluation and analysis could not conclusively determine a root cause for the premature battery depletion.

Event Description

It was reported that the device could not be interrogated.All troubleshooting were unsuccessful in attempt to interrogate the device.The device was explanted and replaced.The patient exhibited symptoms of cardiogenic shock prior to the procedure, but was in stable condition following the device replacement.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: UNIFY 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: 4372235
• MDR Text Key: 5440972
• Report Number: 2938836-2014-19366
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2010
• 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: 68 YR