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

Model Number CD3215-36

Device Problems Premature Discharge of Battery (1057); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fainting (1847); No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient presented in the hospital after receiving inappropriate shock.During the arrhythmia episode atp failed to stop the vt, which accelerated into the vf zone and shock was delivered.The episode was long and the patient fainted.The patient was recovering in the hospital and was stable.The physician decided not to make any programming changes, instead, patient's medication will be adjusted.

Event Description

New info received: the device was explanted and replaced due to battery depletion.Procedure was completed without any complications.

• Brand Name: PROMOTE ACCEL ICD
• 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: 5842091
• MDR Text Key: 50998678
• Report Number: 2938836-2016-06808
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PP030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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: CD3215-36
• Device Lot Number: 3109919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2010
• 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