MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3211-36

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problems Fainting (1847); Ventricular Tachycardia (2132)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the syncopal patient presented with ventricular tachycardia in the emergency room.The device was in backup vvi mode.The device was explanted and replaced after a failed attempt to resolve the issue via a software download.The patient was stable post procedure and will continue to be monitored.

Manufacturer Narrative

No conclusion code available.Final analysis found the reported field event of backup vvi (bvvi) was confirmed in the laboratory and was due to a power-on reset (por) that occurred while delivering hv therapy.The device was tested on the bench and no anomalies were found.The cause of the por could not be determined.

• Brand Name: PROMOTE PLUS CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5330774
• MDR Text Key: 34523409
• Report Number: 2938836-2015-32630
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2015

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: 10/31/2011
• Device Model Number: CD3211-36
• Device Lot Number: 3102183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2016; 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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: 72 YR