MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FORTIFY ASSURA VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1359-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A decision was made on (b)(6) 2016 to report all prophylactic explants that are reported to st.Jude medical (sjm).Therefore, (b)(6) 2016 is used as the aware date for all prophylactic explants occurring prior to this date.Based on the information received, the device was prophylactically removed and there is no alleged malfunction of the product.Should the device be returned and the analysis results indicate an anomaly a follow up report will be submitted.(b)(4).

Event Description

Following the advisory for premature battery depletion with implantable cardioverter defibrillator, although there was no eri alert or allegation of premature battery depletion, the device was explanted prophylactically.

Manufacturer Narrative

Please retract this mdr 2938836-2016-23877.The complaint was reported and filed on (b)(6) 2016, mfr report # 2938836-2016-15664.

• Brand Name: FORTIFY ASSURA VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6213493
• MDR Text Key: 63547410
• Report Number: 2938836-2016-23877
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: CD1359-40Q
• Device Lot Number: 4431080
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Date Device Manufactured: 01/21/2014
• 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