MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA¿ XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D4

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

Patient Problems Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Swelling (2091); Neck Pain (2433)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6935m62 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced an infection.It was noted the patient also had erosion, pain in their right neck, soft tissue swelling erythema, a hematoma, bruising and drainage.It was also reported that antibiotic treatment was used.The crt-d system was extracted.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9931856
• MDR Text Key: 186676319
• Report Number: 3004209178-2020-06783
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007239
• UDI-Public: 00643169007239
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2017
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Date Device Manufactured: 01/11/2016
• 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: 5071-35 LEAD, 5071-35 LEAD,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 111