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

Model Number	DTBB1QQ
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Concomitant medical products: mcs-p3-31-aoa-us transcatheter valve, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, the cardiac resynchronization therapy defibrillator (crt-d) set screw backed out of the header and fell out of the device.The device was not used, and another device was implanted.No patient complications have been reported as a result of this event.

• 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: 8553019
• Report Number: 3004209178-2019-08339
• Device Sequence Number: 16755105
• Product Code: NIK
• UDI-Device Identifier: 00643169929401
• UDI-Public: 00643169929401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR