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

Model Number DTBB1Q1

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

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

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 439888 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient may have received inappropriate therapy for a cardiac resynchronization therapy defibrillator (crt-d) defined ventricular tachycardia (vt) episode.Follow up with the patient's clinic yielded no further information.The crt-d remains in use.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: 7643350
• MDR Text Key: 112512152
• Report Number: 3004209178-2018-14497
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169530201
• UDI-Public: 00643169530201
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2018
• Device Model Number: DTBB1Q1
• Device Catalogue Number: DTBB1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Date Device Manufactured: 01/11/2017
• 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: 694765 LEAD, 5076-52 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR