MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40C

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Device Output (1435)

Patient Problems Bradycardia (1751); Fatigue (1849); Weakness (2145); Heart Failure (2206)

Event Date 06/09/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in the emergency department in profound sinus bradycardia.The patient was weak and fatigued and in heart failure.The implantable cardioverter defibrillator was unable to be interrogated and exhibited no output.The device was explanted and replaced which improved patient symptoms.The patient was in stable condition post procedure.

Manufacturer Narrative

This supplemental report is to correct the initial mdr reported report subtype:bi monthly and report due date: (b)(6) 2017.The correct report subtype and due date to supersede the initial ones are 30 day and (b)(6) 2017.Section g7 initially reported as initial but should have also had 30-day marked.The (b)(4): premature discharge of battery was also added to section device codes, which was not included in the initial mdr.

Event Description

It was reported that the implantable cardioverter defibrillator also exhibited premature battery depletion.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6706431
• MDR Text Key: 79799880
• Report Number: 2017865-2017-05437
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• 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
• Report Date: 08/10/2017

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: 11/30/2015
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: 4368535
• Other Device ID Number: 05414734508186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 06/09/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2013
• 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: 77 YR