MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ XT DR MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number DDPA2D1

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Pacing Problem (1439)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: 694965 lead - implanted (b)(6) 2006 ; 5076-58 lead - implanted (b)(6) 2008.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during the implant procedure the implantable cardioverter defibrillator (icd) exhibited setscrew problems as it was unable to get good contact with lead to pace.When the right ventricular (rv) lead was inserted there was no pacing occurring.  the set screw did tighten and make the clicking noise but no pacing occurred.  the device was removed and a new device was implanted. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b5, annex a product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during the implant procedure the implantable cardioverter defibrillator (icd) exhibited setscrew problems as it was unable to get good contact with lead to pace or capture.When the right ventricular (rv) lead was inserted there was no pacing occurring.  the set screw did tighten and make the clicking noise but no pacing occurred.The device was removed and a new device was implanted. no patient complications have been reported as a result of this event.

• Brand Name: COBALT¿ XT DR MRI SURESCAN¿
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 19056223
• MDR Text Key: 340451665
• Report Number: 9614453-2024-01364
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000178338
• UDI-Public: 00763000178338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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 Model Number: DDPA2D1
• Device Catalogue Number: DDPA2D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• 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: PJN701314V LEAD.
• Patient Age: 67 YR
• Patient Sex: Male