MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA¿ S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTBB1D4
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6947m62 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that therapy was inappropriately withheld for an episode of ventricular tachycardia (vt).The cardiac resynchronization therapy defibrillator (crt-d) remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ S CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9129427
• Report Number: 3004209178-2019-18554
• Device Sequence Number: 13909656
• Product Code: NIK
• UDI-Device Identifier: 00643169007178
• UDI-Public: 00643169007178
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 12/14/2014
• Device Model Number: DTBB1D4
• Device Catalogue Number: DTBB1D4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/27/2019
• 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: 5076-52 LEAD, 419588 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 65 YR
• Patient Weight: 203