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

Model Number	DTBB1QQ
Medical Device Problem Codes	Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2020
Type of Reportable Event	Malfunction
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 cardiac resynchronization therapy defibrillator (crt-d) exhibited a lead integrity alert (lia) that was caused by the patient using a transcutaneous electrical nerve stimulation (tens) unit.The alert was programmed off and the crt-d remains in use.No patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ QUAD S CRT-D
• 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: 10161975
• Report Number: 3004209178-2020-10469
• Device Sequence Number: 11533946
• Product Code: NIK
• UDI-Device Identifier: 00643169530218
• UDI-Public: 00643169530218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: Lay User/Patient
• Device Expiration Date: 07/28/2018
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2020
• Initial Report FDA Received Date: 06/17/2020
• 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: 429888 LEAD, 6947M62 LEAD, 407645 LEAD
• Patient Age: 76 YR