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

Model Number DTPA2QQ

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4798 lead; 6947m lead, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's scar was not completely closed.Scar control treatment was administered, which resolved the issue and the cardiac resynchronization therapy defibrillator (crt-d) remains in use.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: COBALT XT 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: 11769672
• MDR Text Key: 248801417
• Report Number: 9614453-2021-01841
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2022
• Device Model Number: DTPA2QQ
• Device Catalogue Number: DTPA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Date Device Manufactured: 02/18/2021
• 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: 5076 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 121