MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D4

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Electromagnetic Interference (1194); High impedance (1291); Mechanical Problem (1384); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problems Syncope (1610); Cardiac Arrest (1762); Dizziness (2194); Shock from Patient Lead(s) (3162)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency room after multiple shocks and dizziness/syncope.Upon interrogation, there was an right ventricular (rv) lead integrity alert (lia) that triggered due to short ventricular intervals and high rate non-sustained episodes.Multiple rv oversensing events caused the device to inappropriately shock the patient for ventricular fibrillation (vf).It was noted the right atrial (ra) lead sensing was inappropriate, as the ra lead electrograms (egm) stopped showing the patient¿s atrial fibrillation (af) and mirrored the rv egm.There was also a warning for ra lead, rv lead, and left ventricular (lv) lead impedance.The rv lead was unable to capture except at max output and the lv lead was noted to not capture at all.It was noted the patient¿s symptoms and asystole were due to the pacing inhibition during lead noise.The device was reprogrammed, and the patient was admitted until the replacement procedure.It was noted that later the ra, rv, and lv lead impedance rose to high undefined impedance.During replacement surgery, each lead was analyzed individually and found to be working correctly via the analyzer.Each was also reconnected to the old device and again failed to sense/capture appropriately.Fluoroscopy showed all the leads remained in position.The device was explanted and replaced for a potential header issue.When the new device was attached all 3 leads worked correctly.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.A high current drain condition was found during device analysis.Device analysis revealed that the device failed the automated functional test for lead impedance measurements, sensing and pacing output.The device functional test failures were confirmed on the bench using the 2090, lab and universal lab programmers.Hybrid analysis revealed that the reported pacing, sensing, and lead impedance anomalies were due to a leaky xtc009 tantalum capacitor.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA¿ XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9510734
• MDR Text Key: 173886450
• Report Number: 3004209178-2019-24338
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530157
• UDI-Public: 00643169530157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• 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,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2017
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 89 YR