MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40C

Device Problem Sensing Intermittently (1558)

Patient Problems Death (1802); Undesired Nerve Stimulation (1980); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Shock from Patient Lead(s) (3162)

Event Date 12/30/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient did not receive therapy during vt/vf episodes.When the patient was checked in the emergency room, it was noted tachycardia therapy was off.The patient was rescued externally but has been unresponsive.When the patient was seen in (b)(6), rv lead dislodgement, oversensing of atrial events with inappropriate shocks were noted.Therapy was disabled at that time, and bi-v pacing was turned on.Loss of capture was also noted during lead testing at later date.Phrenic nerve stimulation was suspected.Since the device was intermittently sensing r-waves, the physician was afraid of running into pacing on a t-wave, and elected to turn pacing off.The physician planned to revise the lead when the patient becomes stable.The patient was transferred to a different hospital and expired a few days later.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5485712
• MDR Text Key: 39863005
• Report Number: 2938836-2016-01711
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• 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
• Report Date: 02/19/2016

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: 07/31/2016
• Device Model Number: CD3365-40C
• Device Lot Number: 4745101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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
• Patient Age: 42 YR