“…This describes a permanent malfunction of a pacemaker due to conscious or inadvertent manipulation of the pulse generator on its long axis. It occurs commonly in middle-aged women with too spacious pacemaker pocket and in elderly patients with loose subcutaneous tissues [2][3][4][5].…”
Section: Discussionmentioning
confidence: 99%
“…Some measures to prevent future occurrence include creating small pocket as well as the use of Dacron patch that promote tissue in-growth during implantation. Others include patient education before discharge and careful follow-up especially in the first few months of implantation [3,4,7].…”
A 75 year old woman with unipolar ventricular pacemaker presented with cough, difficulty breathing and dizziness. An initial electrocardiogram (ECG) showed atrial fibrillation, incomplete right bundle branch block with no pacemaker spikes. The chest radiograph revealed twisting of the leads at various points. She was managed conservatively with anti-failure drugs and monthly ECG. The pacemaker could not be interrogated due to logistic reasons. However, the ECG during the 8th month of follow-up showed pacemaker spikes and complete left bundle branch block pattern suggestive of spontaneous return of pacemaker function.
“…This describes a permanent malfunction of a pacemaker due to conscious or inadvertent manipulation of the pulse generator on its long axis. It occurs commonly in middle-aged women with too spacious pacemaker pocket and in elderly patients with loose subcutaneous tissues [2][3][4][5].…”
Section: Discussionmentioning
confidence: 99%
“…Some measures to prevent future occurrence include creating small pocket as well as the use of Dacron patch that promote tissue in-growth during implantation. Others include patient education before discharge and careful follow-up especially in the first few months of implantation [3,4,7].…”
A 75 year old woman with unipolar ventricular pacemaker presented with cough, difficulty breathing and dizziness. An initial electrocardiogram (ECG) showed atrial fibrillation, incomplete right bundle branch block with no pacemaker spikes. The chest radiograph revealed twisting of the leads at various points. She was managed conservatively with anti-failure drugs and monthly ECG. The pacemaker could not be interrogated due to logistic reasons. However, the ECG during the 8th month of follow-up showed pacemaker spikes and complete left bundle branch block pattern suggestive of spontaneous return of pacemaker function.
“…Ventricular fibrillation of the heart is lethal. (Avitall, 1994) reports of a patient (49 year old white female) who was implanted with an ICD; a fairly normal procedure. After being discharged and over months, she started to play with the new bump under her skin (the implanted ICD) and eventually caused the device to become loose under her skin.…”
This paper examines safety aspects of medical devices such as: electronics, software, biological, toxicological, physiological, environmental, and even psychological factors. The views of different regulatory bodies in the world on approvals of medical devices are compared and contrasted. Examples of tradeoffs in design of medical devices and issues that face medical device engineers are presented. Risk assessment and mitigation techniques are discussed. Also, legal aspects of medical device safety are visited.
“…1 While it has been well described among pacemaker patients, it is relatively uncommon in patients with an ICD. [2][3][4][5][6][7] We report the case of a patient with inappropriate ICD shocks caused by ventricular lead displacement from the extreme rotation of the ICD generator following vigorous upper extremity exercise.…”
Section: Introductionmentioning
confidence: 99%
“…In a second operation, the old ventricular lead was extracted and a new active fixation ventricular lead (Durata 7120Q, dual coil screw lead, St. Jude Medical Inc.) was implanted in the right ventricular mid-septum area. The generator was fixed more deeply in the pocket using a non-absorbable ligature.DiscussionTwiddler's syndrome is relatively rare in patients with ICD.This may be because ICD generators are usually bigger, have less capacious pockets, and are anchored by non-absorbable ligatures more frequently than are pacemakers [2][3][4][5][6][7][8]. Most cases are attributable to the deliberate or subconscious manipulation of the generator by patients.In this case, the patient was obese and the abundant fat tissue around the generator pocket might have facilitated the drooping of the generator.…”
A 43-year-old man who had received mitral and aortic valve replacement surgery underwent the implantation of an implantable cardioverter defibrillator (ICD) for sustained ventricular tachycardia. The patient presented with a sudden jolting sensation in his left upper chest area one year after the device implantation. He had a history of vigorous upper body exercise during the several months of the follow-up period. Device interrogation revealed complete sensing and capture failure. The ventricular lead impedance was in the normal range, but the high voltage impedance had dropped to less than 10 Ω. Four inappropriate shocks for ventricular fibrillation had been delivered due to over-sensing of the atrial signal on the ventricular lead. Chest radiography showed ventricular lead displacement with extreme rotation and flipping-over of the generator. In the lead revision operation, the old ventricular lead was extracted and replaced, and the generator was fixed more deeply in the pocket with a non-absorbable ligature.
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