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

Model Number DTBB1QQ

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6935m55 lead, implanted: (b)(6) 2019 459888 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was loss of capture and pauses noted on a telemetry strip.Follow up concluded this was due to variable right ventricular (rv) lead thresholds and the device feature that monitors the pacing amplitude threshold and adjusts rv lead outputs.The device was reprogrammed and explanted and replaced.The rv lead was reprogrammed, revised, and remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was further reported that the patient was admitted for seizure like activity and long period of pauses was observed on the telemetry.The long period of pauses and loss of capture was due to the device feature that monitors the pacing amplitude threshold and adjusts rv lead outputs.It was noted that there was a possible micodislodgement due to the varying threshold.During the rv lead revision it was noted the rv lead had adhered to a previously implanted lead.There was also a left subclavian occlusion noted.The patient will be scheduled for a lead extraction.It was also noted that the physician elected to replace the cardiac resynchronization therapy defibrillator (crt-d) because they felt there should have been rv safety pacing when loss of capture occurs.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

It was reported that there was loss of capture and pauses noted on a telemetry strip.Follow up concluded this was due to variable right ventricular (rv) lead thresholds, the rv lead output was possibly below the threshold, and the device feature that monitors the pacing amplitude threshold and adjusts rv lead outputs.The device was reprogrammed and explanted and replaced.The rv lead was reprogrammed, revised, and remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA¿ QUAD S CRT-D
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8798401
• MDR Text Key: 151302530
• Report Number: 3004209178-2019-13699
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720145
• UDI-Public: 00643169720145
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2019

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: 02/28/2020
• Device Model Number: DTBB1QQ
• Device Catalogue Number: DTBB1QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/17/2019; 07/15/2019; 08/01/2019
• Supplement Dates FDA Received: 07/17/2019; 07/24/2019; 08/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• 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: 1388TC46 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR