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

Model Number DTBA1D4

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Congestive Heart Failure (1783); Endocarditis (1834); Unspecified Infection (1930); Renal Failure (2041); Respiratory Distress (2045); Sepsis (2067); Shock from Patient Lead(s) (3162)

Event Date 04/21/2015

Event Type  Injury  

Event Description

It was reported the patient developed endocarditis and that there was perforation of the right ventricular lead.The implantable cardioverter defibrillator (icd) was explanted.The patient was enrolled in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

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

Event Description

Additional information was received and reported that endocarditis was initially suspected however the patient left against medical advice and did not receive a full workup.The patient then was readmitted with respiratory distress, was intubated.The patient was admitted to the hospital with chronic obstructive pulmonary disease exacerbation, congestive heart failure and was then transferred to another hospital for explant.After transfer, the patient was diagnosed with endocarditis, septic emboli, an embolic stroke and renal failure.

Manufacturer Narrative

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

Event Description

It was further reported the patient received high voltage therapy for atrial fibrillation with a rapid ventricular response.The patient was treated with medications.

• Brand Name: VIVA XT
• 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 4969952
• MDR Text Key: 6074606
• Report Number: 3004209178-2015-14875
• Device Sequence Number: 1
• Product Code: NIK
• 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: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2015
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Date Device Manufactured: 03/18/2014
• 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: 4196-88 LEAD, 6947M62 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00053 YR