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

Model Number DTBA1D1

Device Problems Mechanical Problem (1384); Over-Sensing (1438); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 694765 lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead integrity alert (lia) had triggered as well as an alert for noise/oversensing.The lead was suspected of a fracture.Noise could be reproduced with isometrics.The physician wasn't certain if there was an implantable cardioverter defibrillator (icd) header issue causing the oversensing.Follow up with the company representative indicated the patient was scheduled for a lead revision; however, the lead was initially reprogrammed.The device remains in use.No 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 during an attempted right ventricular (rv) lead revision, it was noted the patient was completely occluded.Intervention was completed and the lead remains in use.The implantable cardioverter defibrillator (icd) was explanted and replaced.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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Visual examination of the connector noted cautery marks were present.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA XT
• 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: 7678276
• MDR Text Key: 113678001
• Report Number: 3004209178-2018-15507
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169007246
• UDI-Public: 00643169007246
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

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: 01/28/2017
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 08/02/2018; 08/03/2018; 08/07/2018; 08/08/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/02/2018; 08/02/2018; 08/06/2018; 08/13/2018; 10/02/2018; 10/02/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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, 419688 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR