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

Model Number CD3231-40Q

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

Patient Problems Death (1802); Dyspnea (1816); Palpitations (2467); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the information received, the device was prophylatically 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.

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

Analysis was normal.No anomalies were found.

Event Description

New information received notes that the patient expired.The patient was admitted to the hospital on (b)(6) 2016 for elective device replacement and the device was replaced on (b)(6) 2016.The patient was released one week later.The patient was at home only for one day and transferred to the hospital via ambulance.The patient was in the hospital for two and half weeks and later expired.There is no allegation from a health care professional that the death was device related.The cause of death is unknown and no further information is available at this time.

Event Description

New information received states that a week after the replacement procedure the patient had palpitations and was having shortness of breath.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 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: 6195166
• MDR Text Key: 63055655
• Report Number: 2938836-2016-20226
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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: 11/15/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3450731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 10/25/2017
• Supplement Dates FDA Received: 04/11/2017; 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2011
• 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): Death; Required Intervention
• Patient Age: 86 YR