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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Itching Sensation (1943)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that approximately two weeks post implant of the cardiac resynchronization therapy defibrillator (crt-d) the patient experienced pruritus and a red raised rash around the incision site circumferentially around the skin adhesive.There was a small area that was superiorly unopposed, adhesive bandages were applied to the incision.The patient was treated with oral and topical antibiotics.The 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¿ 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: 14311043
• MDR Text Key: 290942097
• Report Number: 9614453-2022-01299
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2023
• Device Model Number: DTPB2QQ
• Device Catalogue Number: DTPB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Date Device Manufactured: 03/07/2022
• 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: 407652 LEAD, 429888 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 152 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White