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	Ventricular Tachycardia (2132)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 0155 lead, implanted (b)(6) 2002, 4087 lead, implanted (b)(6) 2002.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 was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one day after a routine device upgrade from a implantable cardioverter defibrillator (icd) to cardiac resynchronization therapy defibrillator (crt-d), the patient experienced ventricular tachycardia (vt), received three shocks and anti-tachycardia pacing, and presented to the emergency room.The physician stated that the change from minimal ventricular pacing to pacing may have caused the vt.The device was reprogrammed to avoid right ventricular pacing and it remains in use.It was noted that the vt persisted after the programming changes, and the patient was started on medication; there has been no further vt since the anti-arrhythmic medication.The patient was a participant in the attain stability quad study.No further patient complications have been reported as a result of this event.

• 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: 7094383
• Report Number: 3004209178-2017-25468
• Device Sequence Number: 1461587
• Product Code: NIK
• UDI-Device Identifier: 00643169530201
• UDI-Public: 00643169530201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 03/28/2018
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 12/07/2017
• 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: 4798 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 77 YR