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

Model Number CD3261-40

Device Problems Failure to Interrogate (1332); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was transported from a previous hospital to the emergency room following an external defibrillation.The patient presented with heart failure.The device could not be interrogated and no biventricular pacing was seen.The patient had episodes of torsade de pointes tachycardias without therapy from the icd.An external pacemaker was implanted temporarily.The patient was transported to the icd after intubation and connection to a medical ventilator.The icd was explanted, replaced and discarded by the customer.The patient is unstable.

• 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: 6338824
• MDR Text Key: 67667005
• Report Number: 2938836-2017-15075
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2014
• Device Model Number: CD3261-40
• Device Lot Number: 4123696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2013
• 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: 78 YR
• Patient Weight: 80