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

Model Number	DTBB1Q1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: product id: 6945-65 lead, implanted: (b)(6) 1999, product id: 6940-52 lead, implanted: (b)(6) 1999.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient¿s spouse called to report the patient ¿has a staph infection on the leads".Caller also reported that the patient alert tone was going off multiple times a day.It was further reported the patient subsequently died.Follow up indicated the patient was placed in hospice and had the implantable cardioverter defibrillator (icd) turned off.There was no other information was made available.

• 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: 8519153
• Report Number: 3004209178-2019-07523
• Device Sequence Number: 13856112
• Product Code: NIK
• UDI-Device Identifier: 00643169017993
• UDI-Public: 00643169017993
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 02/14/2017
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: 429878 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR