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

Model Number CD3235-40Q

Device Problem Defective Alarm (1014)

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

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The device was explanted due to an inability to trigger the vibration alert during testing.

Manufacturer Narrative

Evaluation summary: interrogation of the device revealed the device was above eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The device functionality was bench tested and no anomaly was detected.Based on this information, there was no evidence of device malfunction.

• Brand Name: UNIFY CRT-D
• 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: 6166486
• MDR Text Key: 62129770
• Report Number: 2938836-2016-16259
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030054
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: CD3235-40Q
• Device Catalogue Number: CD3235-40Q
• Device Lot Number: 3535230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2011
• 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): Required Intervention