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

Model Number DTPA2D1

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problem Discomfort (2330)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported during a generator change that the right atrial (ra) lead exhibited noise, leading to false detection of atrial fibrillation (af).Lead sensitivity was adjusted, and noise was no longer reproducible with provocative maneuvers.It was reported that the superior vena cava (svc) defibrillation coil of the right ventricular (rv) lead exhibited chronic high and variable impedance.The coil had previously been turned off and the lead remained in use as the pacing and second defibrillation portions of the lead yielded stable test results.During the generator change, rv pacing thresholds were noted to have increased when the lead was connected to the new generator.Several test measurements were taken, and the thresholds were still higher with the new generator.The physician checked the lead connection, reseated the connector pin in the device header and performed a tug test with the same result.A few days post-generator change, thresholds were noted to have risen and be high.Rv pacing impedance had been stable immediately post-generator change but had since risen to a high level.The patient was seen in clinic.Sensing and pacing output was adjusted, a large safety margin was set for pacing output, impedance alerts were tightened, and tachycardia detections were turned off to prevent any inappropriate defibrillation shocks.The patient was seen again shortly thereafter for a device and wound check.All lead testing yielded stable results and tachycardia detections were turned back on.The ra and rv leads remain in use.Additional information received noted that the physician had the patient come in for elective repositioning of the cardiac resynchronization therapy defibrillator (crt-d) within the pocket as the device had moved slightly lateral and was uncomfortable for the patient.During repositioning, the physician took the opportunity to check the connection of the sensing/pacing portion of the rv lead.Upon checking, the physician noted that the pin was not fully engaged in the header from the recent device change.The physician re-engaged the pin fully within the header and proceeded with impedance threshold testing.It was noted that all of the testing were normal in both vectors.The device and lead remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: 419478 lead implanted: (b)(6) 2008 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: COBALT¿ XT HF 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: 18830195
• MDR Text Key: 336855337
• Report Number: 9614453-2024-00897
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTPA2D1
• Device Catalogue Number: DTPA2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Date Device Manufactured: 09/26/2023
• 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: 5554 LEAD, 6944 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization