MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB2D4

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

Patient Problem Syncope (1610)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced syncope due to the cardiac resynchronization therapy defibrillator (crt-d) not applying inappropriate therapy.The device recorded an episode of fast ventricular tachycardia but did not discharge the shock because the noise shopped.It was noted that the device had 11 seconds of noise/interference due to the patient in contact with a stove causing short v-vs.Reprogramming was done, and the device remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to electromagnetic interference/noise.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced syncope due to the cardiac resynchronization therapy defibrillator (crt-d) not applying inappropriate therapy.The device recorded an episode of fast ventricular tachycardia but did not discharge the shock because the noise stopped.It was noted that the device had 11 seconds of noise/interference due to the patient in contact with a stove causing short v-vs.Reprogramming was done, and the device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: AMPLIA MRI CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8700454
• MDR Text Key: 148061446
• Report Number: 9614453-2019-01945
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010031
• 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: 06/17/2019

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: Lay User/Patient
• Device Expiration Date: 02/14/2019
• Device Model Number: DTMB2D4
• Device Catalogue Number: DTMB2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/16/2019
• Supplement Dates FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2017
• 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
• Treatment: 5076-52 LEAD, 6947M62 LEAD, 429688 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention