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	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4592 lead, implanted (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient may have received inappropriate anti-tachycardia pacing and high voltage therapy from the cardiac r esynchronization therapy defibrillator (crt-d) for atrial fibrillation with rapid ventricular response that was detected as ventricular fibrillation (vf).The crt-d remains in use.Intermittent undersensing was also noted on the right atrial (ra) lead.The lead re mains in use.No further 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: 9941830
• Report Number: 3004209178-2020-06927
• Device Sequence Number: 11586612
• Product Code: NIK
• UDI-Device Identifier: 00643169720251
• UDI-Public: 00643169720251
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 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: 03/20/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: 6947M62 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 83 YR