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

Model Number CD3231-40

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Output Problem (3005)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 11/15/2014

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department after receiving inappropriate therapy.Upon interrogation, alerts for possible hv circuit damage and possible hv lead issue were noted.The device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The reported inappropriate therapy delivery was confirmed in the laboratory via stored electrograms and was due to noise.The cause of the noise could not be determined.The reported output anomaly was confirmed in the laboratory.The device was tested on the bench as well as using automated test equipment, and the high voltage output circuitry was noted to be damaged.The cause of the damage could not be determined.

• Brand Name: UNIFY 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: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4372227
• MDR Text Key: 5114240
• Report Number: 2938836-2014-19353
• 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

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: 12/31/2013
• Device Model Number: CD3231-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2012
• 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: 6947-65, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR