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	Invalid Sensing (2293)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: 5076 lead implanted (b)(6) 2017; 6947 lead implanted (b)(6) 2008.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was classifying ventricular tachycardia (vt) as supra ventricular tachycardia (svt) due to gradual onset and withheld therapy.The vt detection zone was decreased so that slow vt would fall into the detection zone.The device feature which helps prevent detection of sinus tachycardia as vt by evaluating the acceleration of the ventricular rate was also set to monitor-only.The patient was non-specifically symptomatic due to the slow vt and was treated with medication to return them to normal sinus rhythm.The device remains in use.A high left ventricular (lv) lead threshold had also been recently observed.The lead remains in use.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: 6923070
• Report Number: 3004209178-2017-20991
• Device Sequence Number: 10939078
• Product Code: NIK
• UDI-Device Identifier: 00643169530201
• UDI-Public: 00643169530201
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/16/2017

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: 04/14/2018
• 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: 07/16/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: Required Intervention
• Patient Age: 56 YR