MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRG

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

Patient Problems Death (1802); Endocarditis (1834); Hemorrhage/Bleeding (1888); Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 08/18/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 694765 lead, implanted: (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient developed a pocket infection and endocarditis.Antibiotic treatment was initiated and explanted of the cardiac resynchronization therapy defibrillator (crt-d) system was attempted.After removal of leads, the patient became hypotensive and developed significant bleeding believed to be due to an avulsion of the innominate vein.Chest compressions and a sternotomy were performed, however the patient was not able to be revived.A cause of death of complications of massive bleeding with hemothorax was provided.The patient was a participant in the product surveillance registry clinical study.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.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: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7050221
• MDR Text Key: 92669994
• Report Number: 3004209178-2017-24190
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994677884
• UDI-Public: 00613994677884
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

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: 04/28/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2012
• 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: 5568-53 LEAD, 4543 LEAD.
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 89