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

Model Number DTMC2QQ

Device Problems Over-Sensing (1438); Decreased Sensitivity (2534)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-operative to a left ventricular assist device (lvad) implant procedure, the left ventricular lead threshold was high.The lead remains in use.It was also reported that a lead integrity alert was triggered for short v-v intervals and non-sustained ventricular tachycardia episodes, and r wave sensing was low.Noise could not be reproduced on the ventricular electrogram and when performance data was reviewed, it revealed the oversensing only took place for one hour, which indicated electromagnetic interference (emi) may have affected the cardiac resynchronization therapy defibrillator (crt-d) at that time.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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 non-physiologic signals/sensing integrity counter.Analysis of the device memory ind icated diminished right ventricular sensing.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.

Event Description

It was reported that post-operative to a left ventricular assist device (lvad) implant procedure, a lead integrity alert was triggered for short v-v intervals and non-sustained ventricular tachycardia episodes, and r wave sensing was low.Noise could not be reproduced on the ventricular electrogram and when performance data was reviewed, it revealed the oversensing only took place for one hour, which indicated electromagnetic interference (emi) may have affected the cardiac resynchronization therapy defibrillator (crt-d) at that time.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was later reported that a follow-on surgery to the lvad procedure was necessary, which was the source of the emi that affected the crt-d.

• Brand Name: COMPIA 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: 7996545
• MDR Text Key: 124736335
• Report Number: 9614453-2018-03645
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2019
• Device Model Number: DTMC2QQ
• Device Catalogue Number: DTMC2QQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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
• Treatment: 5076-52 LEAD, 6935M-62 LEAD, 4798-88 LEAD