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

Model Number DTMA1QQ

Device Problems Intermittent Capture (1080); Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a system upgrade, the left ventricular (lv) lead was tested through the analyzer and all vectors were within acceptable range.However, when the lv lead was attached to the cardiac resynchronization therapy defibrillator (crt-d), the lead exhibited only intermittent capture in all vectors, and high threshold noted with additional vector testing.Additionally, manual testing exhibited intermittent capture at 5 volts.The lv lead was tested again through the analyzer and all thresholds were normal.A different crt-d was selected, the lv lead was connected, and again intermittent capture at 5 volts in all vectors.Troubleshooting was performed disconnecting the lv lead, tightening device set screw, and similar results occurred.Pocket manipulation was also performed, and no non-physiologic artifact was observed.On reattempt of manual lv threshold measurements, lv capture was successful.During the troubleshooting of the lv lead, a connection issue was suspected.Through additional troubleshooting it was noted that the patient was effectively bi-ventricular pacing.Since bi-ventricular pacing was confirmed and there was no difference in behavior with the second crt-d, the physician chose to re-connect the lv lead to the first crt-d.It was noted that all measurements were within range, subsequent lv threshold testing produced acceptable measures and pacing capture was evident.The crt-d and lv l ead were implanted and remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA MRI QUAD 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 ; SZ 1131
• MDR Report Key: 11219515
• MDR Text Key: 258692408
• Report Number: 9614453-2021-00285
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059514
• UDI-Public: 00763000059514
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7741 LEAD, 0286 LEAD
• Patient Age: 43 YR
• Patient Weight: 113