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

Model Number	DTBB1D4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5086mri45 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was explanted due to an infection.The device system was later replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Concomitant medical product: tyrx-aae absorbable envelope implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received which noted the patient was also implanted with an absorbable envelope.

• Brand Name: VIVA QUAD S
• Common Device Name: 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
• MDR Report Key: 7651410
• Report Number: 3004209178-2018-14686
• Device Sequence Number: 1817942
• Product Code: NIK
• UDI-Device Identifier: 00643169929388
• UDI-Public: 00643169929388
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2019
• Device Model Number: DTBB1D4
• Device Catalogue Number: DTBB1D4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6947M55 LEAD, 419688 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR