MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3267-40Q

Device Problem Vibration (1674)

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

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a follow-up, the patient was not able to feel the vibratory alert, even when the alert worked correctly.The device was reprogrammed to increase the duration of the vibratory alert with no resolution.The device was explanted and replaced and the patient was stable.

Manufacturer Narrative

The device was tested in the lab and no anomalies were found.The patient notifier was also tested and revealed no anomaly.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

• Brand Name: QUADRA ASSURA DDQP+
• 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: 6225104
• MDR Text Key: 63948298
• Report Number: 2938836-2017-00302
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/30/2017

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: 02/28/2015
• Device Model Number: CD3267-40Q
• Device Lot Number: 4201136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 83 YR