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

Model Number CD3261-40

Device Problem Programming Issue (3014)

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

Event Date 01/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).

Event Description

The patient was admitted to the hospital with atrial and ventricular tachycardia.Due to the programming of the device, the incorrect discriminators were applied and no therapy was delivered.The device was reprogrammed to resolve the issue and the patient was stable.

• Brand Name: UNIFY 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: 6323560
• MDR Text Key: 67164235
• Report Number: 2938836-2017-14433
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 01/23/2017

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: 12/31/2014
• Device Model Number: CD3261-40
• Device Lot Number: 4130091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2013
• 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: 76 YR