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 Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 419588 lead; 6935m62 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 cardiac resynchronization therapy defibrillator (crt-d) battery was rapidly depleting due to high threshold measurements of the left ventricular (lv) lead.It was noted that the lv lead had intermittent loss of pacing capture.The device was explanted and replaced, and the lead was capped and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: performance data collected from the device was received and analyzed.Analysis of the device memory showed the battery is approaching the indicator signifying the time for device replacement.Information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• 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: 9107022
• Report Number: 3004209178-2019-18234
• Device Sequence Number: 2383954
• Product Code: NIK
• UDI-Device Identifier: 00643169929302
• UDI-Public: 00643169929302
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2019

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: 05/28/2019
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 10/01/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 09/30/2019; 10/02/2019
• 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: 68 YR