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

Model Number DTBA1QQ

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the patient that the patient received a shock from the cardiac resynchronization therapy defibrillator (crt-d) when lifting a suitcase while traveling and then "fell on the bed." the device remains in use.The patient was a participant in the adapt response clinical study.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 later clarified the patient stated "feeling like (the patient) received a shock" and upon interrogation, there was no evidence of therapy delivery.

• Brand Name: VIVA QUAD 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: 8038240
• MDR Text Key: 126116340
• Report Number: 3004209178-2018-24661
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720138
• UDI-Public: 00643169720138
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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: 07/28/2019
• Device Model Number: DTBA1QQ
• Device Catalogue Number: DTBA1QQ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/16/2018
• Date Device Manufactured: 02/06/2018
• 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: 6935M-62 LEAD, 4598-88 LEAD, 5076-52 LEAD
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Weight: 145