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); Misconnection (1399)

Patient Problems Dyspnea (1816); Edema (1820)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant product: h601h31 heart ring, implanted (b)(6) 1997, product event summary : the device was not returned for analysis, however performance data was collected from the device and analyzed.Analysis revealed the left ventricular pacing lead¿s impedance began to be measured high, at 4047 ohms, on (b)(6) 2016.

Event Description

It was reported that the patient experienced the return of symptoms associated with congestive heart failure (chf) - specifically, increasing shortness of breath and lower extremity edema - after a routine device replacement procedure.The left ventricular lead had high impedance and high threshold, and an x-ray revealed the lead pin was not fully inserted into the device header.The device set screw was not visible when the physician opened the pocket, and the pin fell out of the header.The pin was re-inserted and the set screw re-tightened, the testing was satisfactory, and the lead and device remain 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.

• 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: 6008280
• MDR Text Key: 56788796
• Report Number: 3004209178-2016-20971
• Device Sequence Number: 1
• Product Code: NIK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

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: 02/28/2017
• Device Model Number: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: 07/07/2016
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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: 6947-65 LEAD, 5076-52 LEAD, 4196-88 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR