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

Model Number DTPB2QQ

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 setscrew, 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 b ehavior 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.

• Brand Name: COBALT HF QUAD CRT-D MRI 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
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11219547
• MDR Text Key: 228386295
• Report Number: 9614453-2021-00284
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178178
• UDI-Public: 00763000178178
• 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
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2022
• Device Model Number: DTPB2QQ
• Device Catalogue Number: DTPB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/22/2021
• Date Device Manufactured: 10/12/2020
• 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 Age: 43 YR
• Patient Weight: 113