open access

Vol 14, No 4 (2019)
Original Papers
Published online: 2019-09-06
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The initial experience with a subset of recalled Medtronic dual chamber pacemakers

Agnieszka Kołodzińska, Przemysław Stolarz, Andrzej Cacko, Diana Paskudzka, Małgorzata Łukaszewicz, Grzegorz Opolski, Marcin Grabowski
DOI: 10.5603/FC.2019.0090
·
Folia Cardiologica 2019;14(4):329-332.

open access

Vol 14, No 4 (2019)
Original Papers
Published online: 2019-09-06

Abstract

Introduction. Medtronic released a subset of dual chamber pacemakers that are suspected of a software error that can result in a lack of pacing. The Food and Drug Administration has deemed a class I recall. Material and methods. Medtronic advise reprogramming for patients with susceptible mode to non-susceptible pacing modes that are: DVI, DVIR, DOO(R), VVI, VVIR, VOO(R), VVT, AAI, AAIR, AOO(R), AAT, OVO. Results. 48 patients received an atrioventricular recalled device. Initially the DDD/DDDR mode was programmed in 44 patients and VVI/VVIR mode in the other four patients. The atrial and ventricular lead parameters such as pacing threshold, sensing threshold and impedance were within normal ranges. Pacemaker dependency in atria concerned 16/48 (33.33%) patients and in ventricles 13/48 (27.1%) patients. Three patients complained of fatigue, dizziness and near syncope. In 24 patients, devices were reprogrammed: in 17 (35.41%) patients to the DVIR mode and in seven (14.58%) patients to the VVI(R) mode. Two patients chose to be reprogrammed to the DDDR mode because of intolerance to non-susceptible pacing modes. Conclusions. Only three patients experienced symptoms that may be associated with pacemaker dysfunction; in 24/48 patients we programmed safety mode DVI(R) or VVI(R). The pacemaker dependency concerned almost 33.33% of patients.

Abstract

Introduction. Medtronic released a subset of dual chamber pacemakers that are suspected of a software error that can result in a lack of pacing. The Food and Drug Administration has deemed a class I recall. Material and methods. Medtronic advise reprogramming for patients with susceptible mode to non-susceptible pacing modes that are: DVI, DVIR, DOO(R), VVI, VVIR, VOO(R), VVT, AAI, AAIR, AOO(R), AAT, OVO. Results. 48 patients received an atrioventricular recalled device. Initially the DDD/DDDR mode was programmed in 44 patients and VVI/VVIR mode in the other four patients. The atrial and ventricular lead parameters such as pacing threshold, sensing threshold and impedance were within normal ranges. Pacemaker dependency in atria concerned 16/48 (33.33%) patients and in ventricles 13/48 (27.1%) patients. Three patients complained of fatigue, dizziness and near syncope. In 24 patients, devices were reprogrammed: in 17 (35.41%) patients to the DVIR mode and in seven (14.58%) patients to the VVI(R) mode. Two patients chose to be reprogrammed to the DDDR mode because of intolerance to non-susceptible pacing modes. Conclusions. Only three patients experienced symptoms that may be associated with pacemaker dysfunction; in 24/48 patients we programmed safety mode DVI(R) or VVI(R). The pacemaker dependency concerned almost 33.33% of patients.
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Keywords

dual chamber pacemaker, recall, Medtronic

About this article
Title

The initial experience with a subset of recalled Medtronic dual chamber pacemakers

Journal

Folia Cardiologica

Issue

Vol 14, No 4 (2019)

Pages

329-332

Published online

2019-09-06

DOI

10.5603/FC.2019.0090

Bibliographic record

Folia Cardiologica 2019;14(4):329-332.

Keywords

dual chamber pacemaker
recall
Medtronic

Authors

Agnieszka Kołodzińska
Przemysław Stolarz
Andrzej Cacko
Diana Paskudzka
Małgorzata Łukaszewicz
Grzegorz Opolski
Marcin Grabowski

References (7)
  1. Urgent Medical Device Recall for a subset of Medtronic dual chamber pacemakers. www.medtronic.com/us-en/healthcare-profesionals/products/product-performance/dual-chamber-pacemaker-recall.html.
  2. Zając D, Blicharz J, Przybylski A, Mitkowski P. et al.. Opinia Grupy Roboczej powołanej przez konsultanta Krajowego w dziedzinie Kardiologii oraz Zarząd Sekcji Rytmu Serca Polskiego Towarzystwa Kardiologicznego na temat zalecanego postępowania u chorych zagrożonych wstrzymaniem stymulacji w dwujamowych stymulatorach firmy Medtronic. 27 stycznia 2019.
  3. www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-dual-chamber-implantable-pulse-generators-ipgs-due-possible-circuit-error.
  4. Lelakowski J, Majewski J, Bednarek J, et al. Pacemaker dependency after pacemaker implantation. Cardiol J. 2007; 14(1): 83–86.
  5. Karczmarewicz G, Ziavina Y, Michalik J, et al. Dlaczego należy diagnozować depresję u chorych z implantowanym układem do elektroterapii serca? Fol Cardiol. 2018; 13(3): 274–278.
  6. www.fda.gov/medical-devices-recalls/medtronic-recalls-cardiac-resynchronization-therapy-and-implantable-cardioverter-defibrillatora-due.
  7. Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001; 286(7): 793–799.

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