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 Death (1802); Endocarditis (1834); Unspecified Infection (1930)

Event Date 10/29/2015

Event Type  Death  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.The initial reported event of infection was received on (b)(6) 2015.Of note, the infection event is normally submitted via am alternative summary report (asr) submission that should have been submitted on (b)(6) 2016.Information was subsequently received on (b)(6) 2015 and revealed the patient died.As there is new information that reasonably suggests the device has or may have caused or contributed to a death, this event no longer qualifies for asr reporting and is therefore being submitted as a 30-day report.Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.(b)(4).

Event Description

It was reported that the patient experienced an infection approximately five months after a device exchange had occurred.Cultures were taken and the patient was treated with antibiotics.The implantable cardioverter defibrillator (icd) system was extracted.It was further reported the patient experienced endocarditis and lead vegetation and that the patient passed away approximately three weeks after the explant of the implantable cardioverter defibrillator (icd) system.The cause of death was noted as septic shock.The source of the infection is not known.

• 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5336678
• MDR Text Key: 34734546
• Report Number: 3004209178-2015-25784
• 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
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2016
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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): Death
• Patient Age: 00073 YR