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

Model Number	DTBA1D4
Medical Device Problem Codes	Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 1688tc lead, implanted: (b)(6) 2006.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the patient they had a routine follow-up appointment where "changes were made." after the appointment, the patient reported hearing "beeping" from the cardiac resynchronization therapy defibrillator (crt-d).It was further reported by the clinic that the cause of the beeping was potentially due to magnet exposure as no alerts were noted on the device.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: VIVA XT 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: 10562875
• Report Number: 3004209178-2020-16363
• Device Sequence Number: 16821182
• Product Code: NIK
• UDI-Device Identifier: 00643169720251
• UDI-Public: 00643169720251
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 09/28/2020
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR