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

Model Number DTPA2D4

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

Patient Problem Twiddlers Syndrome (4563)

Event Date 03/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that all of the patient's leads had been pulled back into the pocket and tangled together as a result of twiddler's syndrome.As a result, the cardiac resynchronization therapy defibrillator (crt-d) system was explanted and replaced.No further patient complications have been reported as a result of this event.

• 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: 14069485
• MDR Text Key: 288991248
• Report Number: 9614453-2022-01026
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178130
• UDI-Public: 00763000178130
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: DTPA2D4
• Device Catalogue Number: DTPA2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Date Device Manufactured: 03/12/2021
• 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: 6935M55 LEAD, 383069 LEAD, 457445 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female