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

Model Number CD3257-40

Device Problems Difficult to Interrogate (1331); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)

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

Event Date 05/28/2014

Event Type  Injury  

Event Description

New information received notes that the device was unable to be interrogated.A magnet was placed over the device to stop therapy.

Manufacturer Narrative

The reported field event of inappropriate therapy could not be confirmed in the laboratory due to a corrupt device image.The reported field event of backup vvi was confirmed in the laboratory and was due to two resets within a short period of time.The cause of the resets could not be determined.

Manufacturer Narrative

All information provided by manufacturer and maude report mw5036437.

Event Description

It was reported that the patient presented to the emergency room after receiving inappropriate high voltage therapy.Device interrogation found the device to be in backup vvi.The patient was transferred to another facility where the device was explanted and replaced.Patient was stable after the event.

Manufacturer Narrative

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

• Brand Name: UNIFY 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: 3897862
• MDR Text Key: 4896162
• Report Number: 2938836-2014-12538
• 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,Followup,Followup
• Report Date: 05/30/2014,05/29/2014

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: 10/31/2014
• Device Model Number: CD3257-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2014
• Distributor Facility Aware Date: 05/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2014
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/13/2014; 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR