MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ DR MRI SURESCAN¿; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number DDPB3D1

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2023

Event Type  Death  

Event Description

It was reported by the patient¿s family member that the patient had passed away from the defibrillator not working.The patient¿s family member stated that it was supposed to shock but it did not.It was noted from the patient¿s obituary that the patient passed away after a lengthy battle with cancer.

Manufacturer Narrative

Continuation of d10: product id 5076-52 lead, implanted: (b)(6) 2020.A voluntary medwatch form 3500 was received (report #mw5115991); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.F1 user facility f2 uf/importer report number: mw5115991.F3 user facility name/address: n/a.F4 contact person: (b)(6).F5 phone number: (b)(6).F6 date user facility became aware of event: (b)(6) 2023.F7 type of report: initial f8 date of this report: 27-mar-2023.F9 approximate age of device: n/a.F10 event problem codes: n/a.F11 report sent to fda: yes.(b)(6) 2023.F12 location where event occurred: n/a.F13 report sent to manufacturer: yes.F14 manufacturer name and address mfr.Name: medtronic, plc addl: 8200 coral sea street ne.City: mounds view.State: mn.Zip: 55112.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¿ DR MRI SURESCAN¿
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16818603
• MDR Text Key: 314043531
• Report Number: 9614453-2023-01460
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00763000178376
• UDI-Public: 00763000178376
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2021
• Device Model Number: DDPB3D1
• Device Catalogue Number: DDPB3D1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/26/2023
• Date Device Manufactured: 05/28/2020
• 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
• Treatment: 693565 LEAD.
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male