MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA QUAD S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBB2QQ

Device Problems Mechanical Problem (1384); Decreased Sensitivity (2534); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's right ventricular (rv) lead exhibited high thresholds, low r-waves, and decreasing impedance since implant.It was decided to reposition the rv lead.The rv lead was repositioned, however the high thresholds and low r-waves remained.It was decided to relocate the rv lead again, however after the helix was retracted it was unable to be extended again.A replacement lead was chosen and implanted, however the physician had difficulties screwing and unscrewing the rv setscrew on the patient's cardiac resynchronization therapy defibrillator (crt-d).It was also reported the replacement rv lead measurements were normal when measured with an analyzer, however the lead showed high thresholds and low r-waves when measured through the crt-d.It was decided to also replace the crt-d.Upon connection with the new crt-d, the replacement rv lead showed normal measurements.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA QUAD S
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7797573
• MDR Text Key: 117604075
• Report Number: 9614453-2018-02937
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: DTBB2QQ
• Device Catalogue Number: DTBB2QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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: 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR