FDA Adverse Event Injury Summary report: N

MEDTRONIC BIVENTRICULAR VIVA CRT

MDR report key: 8464509 · Received March 28, 2019

Report

Report Number
MW5085318
Event Type
Injury
Date Received
March 28, 2019
Report Date
March 26, 2019
Manufacturer
MEDTRONIC, INC.
Product Code
KRG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

ONE HEAD OF THE MEDTRONIC BIVENTRICULAR PACEMAKER TO THE LEFT VENTRICLE HAS STOPPED WORKING. TECH WAS NOT SUCCESSFUL IN GETTING IT TO WORK WITH ADJUSTMENTS. NOW I MUST BE TURNED OFF AND THE PT HAS ONLY THE OTHER VENTRICLE PACING. PT HAS BEEN NOTIFIED THAT HE MAY NEED TO RESORT TO AN EPICARDIAL LEAD PLACEMENT SINCE HE NO LONGER HAS BIVENTRICULAR PACING. THE PT IS TURNING (B)(6) YEARS OLD IN (B)(6) 2019, HAS ATRIAL FIBRILLATION, MITRAL VALVE REPAIR, AND PRONE TO CONGESTIVE HEART DISEASE. MEDICATION ADJUSTMENTS HAVE BEEN MADE AND THE DEVICE HAS BEEN ADJUSTED TO TURN ON ONLY IF HIS HEART RATE DROPS BELOW 50 BPM. PT IS ON BLOOD THINNERS CARDIOLOGIST STATES PT WOULD BE A RISK FOR CORRECTIVE SURGERY BUT IF THE ADJUSTMENTS DO NOT LAST, THE PT WILL REQUIRE THE PLACEMENT OF THE EPICARDIAL LEAD SURGERY. PRODUCT: MEDTRONIC, BIVENTRICULAR VIVA CRT, C6TR01, PVZ601987S, 429688, RRA 589321V, 5076, 58 PJN 3974525 IMPLANTED (B)(6) 2015. PT: (B)(6); CARDIOLOGIST: (B)(6). BY (B)(6) 2017 PT BEGAN HAVING FLUID RETENTION IN LUNGS, SWELLING OF ANKLES, (B)(6) 2018 EKG SHOWED PULMONARY HYPERTENSION WITH RESIDUAL MITRAL STENOSIS. AORTA VALVE HETTING NARROWER, (B)(6) 2018 CARDIOLOGIST INFORMED PT THAT LEAD IS NO LONGER WORKING AFTER RESULTS FROM HOME MONITORING WENT TO THE COMPANY; (B)(6) 2019 PT NOTIFIES IF HEART WEAKENS, HE WILL HAVE TO HAVE THE EPICARDIAL LEAD PLACED. PT IS ON A 3 MONTH REVISIT CHECK. NEXT APPT (B)(6) 2019.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
254621 MEDTRONIC BIVENTRICULAR VIVA CRT PROGAMMER, PACEMAKER KRG MEDTRONIC, INC. C6TR01, PVZ601987S, 429688 PJN3974525

Patients

Seq Age Sex Outcome Treatment
1 Life Threatening| O| R