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

Model Number DTBB1Q1

Device Problems Mechanical Problem (1384); Inappropriate/Inadequate Shock/Stimulation (1574); Component Missing (2306)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The returned device indicated a loose/detached set screw.The returned device indicated a set screw with a rounded socket.Concomitant medical products: 6947-65 lead, implanted: (b)(6) 2003.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient received inappropriate therapy; the lead displayed high thresholds and there was an abrupt increase.It was also reported the lead displayed an abrupt increase in impedance and it was high.Additionally, there was over-sensing and a change in the r wave sensing.Approximately two weeks ago and during ventricular tachycardia there was an increase in the right ventricular pacing impedance.This occurred around the time a left ventricular assist device was placed.At the time of the revision while detaching the lead from the header it was discovered there was not a grommet in the left ventricular port.There was difficulty engaging the screw, but ultimately the lead was removed from the port.The right ventricular lead was capped and replaced.The device was removed and replaced no further patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD S
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7257832
• MDR Text Key: 99571266
• Report Number: 3004209178-2018-02859
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169017993
• UDI-Public: 00643169017993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2017
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 1456Q LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR