MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPA2Q1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4798 lead; 5076 lead implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the emergency department with bleeding from the left antero-superior thoracic orifice at the cardiac resynchronization therapy defibrillator (crt-d) implant site associated with deglobulation.One time dose of globular pellet was administered.After changing the dressing, there was no recurrence of bleeding.The device 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.

• 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: 11066697
• MDR Text Key: 223442604
• Report Number: 9614453-2020-04306
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2021
• Device Model Number: DTPA2Q1
• Device Catalogue Number: DTPA2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Date Device Manufactured: 02/24/2020
• 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: 6935 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85