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

Model Number	DTBB1QQ
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• 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: 8798401
• Report Number: 3004209178-2019-13699
• Device Sequence Number: 14074667
• Product Code: NIK
• UDI-Device Identifier: 00643169720145
• UDI-Public: 00643169720145
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 07/15/2019; 08/01/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/17/2019; 07/24/2019; 08/02/2019
• 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: 1388TC46 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR