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

Model Number DTMB2QQ

Device Problems Electromagnetic Interference (1194); Nonstandard Device (1420); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Noise, Audible (3273)

Patient Problems No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)

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 had an episode of fast atrial fibrillation (af) which fell into the ventricular fibrillation (vf) zone and subsequently received a shock.It was noted there was some noise that can be seen on the signal, which the device no longer considers it to match the template.It was further reported the patient had been apparently using a piece of equipment to refit a bathroom at the time and thought it was this piece of equipment that gave caused the shock.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 the unexpected delivery of ventricular tachyarrhythmia therapy.Analysis of the device memory had an observation relating to the at/af detection.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: AMPLIA MRI QUAD CRT-D
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7767716
• MDR Text Key: 116904889
• Report Number: 9614453-2018-02800
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 08/28/2017
• Device Model Number: DTMB2QQ
• Device Catalogue Number: DTMB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/21/2018; 08/08/2018
• Supplement Dates FDA Received: 08/23/2018; 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0962-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening