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

Model Number	DTBA1QQ
Medical Device Problem Codes	Mechanical Problem (1384); Under-Sensing (1661)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the atrial lead had not been tied down adequately at initial implant and had pulled back.The lead was explanted and replaced.During the revision procedure, the new atrial lead was plugged into the header and there were no sealing rings and the device would not sense the pwaves.The lead was checked okay through the analyzer.It was determined that the lead was not making good contact in the header and therefore not sensing pwaves.The device was then explanted and replaced with a new device.The physician thinks that the sealing rings came out when the old atrial lead was removed from the header.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed and no anomalies were found.Visual examination of the connector noted cautery marks were present.Visual examination of the connector noted blood ingress/body fluid.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA QUAD XT
• 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: 8112805
• Report Number: 3004209178-2018-26442
• Device Sequence Number: 2363952
• Product Code: NIK
• UDI-Device Identifier: 00643169929326
• UDI-Public: 00643169929326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/14/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2019
• Device Model Number: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR