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

Model Number	DTBB1Q1
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6935-65 lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post-operative to a routine cardiac resynchronization therapy defibrillator (crt-d) change-out procedure, the vector express algorithm was run, but the algorithm could not execute due to a fast/competing rhythm so the medical equipment company representative selected ok, but then noticed a-v dissociation because the pacing mode - which had been programmed to a dual sensing and pacing mode (ddd) - was now a ventricular-only sensing and pacing mode (vvi.) the representative observed vvi pacing for about one minute and then reprogrammed the device pacing mode from ddd to vvi and back to ddd, which then caused normal ddd pacing.The device remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary : the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated an observation with pacing mode rates and intervals.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA QUAD S
• 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: 7978726
• Report Number: 3004209178-2018-23342
• Device Sequence Number: 1578993
• Product Code: NIK
• UDI-Device Identifier: 00643169720206
• UDI-Public: 00643169720206
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 06/28/2019
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/28/2018
• 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, 4598-88 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR