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

Model Number 3207-36

Device Problems Failure to Capture (1081); Inappropriate or Unexpected Reset (2959)

Patient Problems Syncope (1610); Death (1802); Loss of consciousness (2418)

Event Date 03/11/2014

Event Type  Death  

Event Description

It was reported that the patient experienced syncope at home and was found unresponsive.Emergency medical technicians externally cardioverted the patient multiple times.Upon arrival at the hospital, the device was found in back-up vvi with hv therapy disabled and no capture was observed.The patient was intubated, a temporary pacing wire was placed and a heart catheterization was performed.It was noted that the device was functioning normally during a follow-up visit four days prior to presenting to the er.While in the ccu the patient had several episodes of torsades and coded several times over the next few days and then expired.

Manufacturer Narrative

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

Manufacturer Narrative

The reported field events of backup vvi and capture anomaly were not confirmed in the laboratory due to the extensive damage present upon receipt.The icd can was noted to be severely compressed and the septum damaged.X-ray inspection noted a large crack present on the hybrid.The cause of the device damage could not be determined.

• Brand Name: PROMOTE RF 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: 3737538
• MDR Text Key: 4219562
• Report Number: 2938836-2014-09310
• 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

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: 01/31/2010
• Device Model Number: 3207-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2014
• Device Age: 62 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2009
• 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: (B)(4)
• Patient Outcome(s): Death
• Patient Age: 71 YR