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

Model Number DTBB1D1

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Sepsis (2067); Ventricular Tachycardia (2132); Shock from Patient Lead(s) (3162)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant product: 1158t lead implanted: (b)(6) 2011.

Event Description

It was reported an infection occurred.The implantable cardioverter defibrillator (icd)system was explanted.It was further reported that the patient presented to the emergency department after a syncopal episode and was found to have pseudomonas bacteremia.Drainage of an abscess, a hematoma evacuation and system extraction were performed.The patient had perioperative ventricular tachycardia (vt) which resolved without intervention possibly due to irritation of myocardium and hypotension secondary to sepsis.The patient was treated with antibiotics and a wound vac was placed.The device system was replaced one week later.No further patient complications have been reported as a result of this event.The patient was a participant in the (b)(6) clinical study.

Event Description

Additional information received reported the patient was seen in device clinic post implant and had dizziness and swelling/ecchymosis over device site.The patient's medications were changed.The patient was later admitted for a fall and inappropriate therapy was provided as high voltage therapy was given for atrial fibrillation with rapid ventricular response.The bacteremia was then found during hospital stay.A transesophageal echocardiogram noted a thrombus in the left atrial appendage but no lead vegetation was observed.

Manufacturer Narrative

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

• 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: 6008025
• MDR Text Key: 56775494
• Report Number: 3004209178-2016-20912
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2017
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Date Device Manufactured: 10/13/2015
• 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
• Treatment: 6945-58 LEAD, 694045 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 67