MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBB1D1

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

Patient Problems Cellulitis (1768); Chest Pain (1776); Erythema (1840); Unspecified Infection (1930)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

Medical devices continued: 5076-52 lead implanted: (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced infection, cellulitis and erythema on device site.The patient was started on antibiotics and subsequently went to the emergency department (ed) with complaints of chest pain.The patient was admitted for observation and treatment of chest pain and device site redness.The patient was discharged to home in stable condition and site redness improved.The patient finished up 5 more days of antibiotics and site redness resolved.The device remains in use.The patient is enrolled in the world-wide randomized antibiotic envelope infection prevention trial (wrap-it) clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

The patient's system was removed.

• Brand Name: VIVA S
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7546486
• MDR Text Key: 109355075
• Report Number: 3004209178-2018-11953
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530218
• UDI-Public: 00643169530218
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2016
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Date Device Manufactured: 05/20/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99