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A pacemaker is a small, battery-powered device that monitors the heart's electrical impulses after it is implanted into the body. It delivers electrical stimuli to the heart when necessary, to induce the heart to beat or contract in a more normal rhythm. A pacemaker is used when a patient's heart has other abnormal rhythms (arrhythmias), beats too slowly (bradycardia), or to treat heart failure. A pacemaker is made up of two basic parts, a generator and wires (leads). Pacemakers can serve specific purposes, according to the Food and Drug Administration (FDA), based on the needs of the heart:

  • Single-Chambered Pacemakers use only one insulated lead placed into the right lower chamber (right ventricle) or the right upper chamber of the heart (right atrium).
  • Dual-Chambered Pacemakers use two leads, with one in the right ventricle and one in the right atrium.
  • Rate-Responsive Pacemakers increase or decrease heart rate to match an individual's activities (such as walking or sleeping).
  • Cardiac Resynchronization Therapy Pacemakers use three leads, with a lead in the right ventricle, right atrium and the heart's veins to the left ventricle.

Pacemaker Risks

The surgery to implant a pacemaker poses some of the following risks:

  • Infection
  • Blood vessel damage
  • Blood vessel damage
  • Blood clot formation
  • Swelling or bruising under the skin
  • Bleeding

Once a pacemaker is inserted, individuals must be wary of electronic interference. Some devices that people encounter on a normal basis can interfere with a pacemaker's operation, as noted by the American Hearth Association, such as household appliances, medical equipment, security devices, or electronic generators.

Defective Pacemaker

Pacemakers have generally been proven effective in treating people with heart conditions. As a result, it is especially difficult for patients who suffer harm from pacemakers that do not function properly. Manufacturers of pacemakers must recall a product if defects have been proven responsible for causing injuries. Some recent recalls listed by the FDA have been made by two of the largest producers of pacemakers, Guidant and Medtronic, including the examples below.

On June 24, 2006, Guidant initiated a recall on several pacemaker models in the following groups of pacemakers:

  • INSIGNIA I Ultra
  • INSIGNIA I Entra
  • NEXUS I Plus
  • NEXUS I Ultra
  • NEXUS Entra

On November 25, 2005, Medtronic recalled multiple models of the Sigma implantable pulse generators (IPGs), including models in the following categories:

  • Single chamber pacemaker
  • Single chamber rate responsive pacemaker
  • Dual chamber atrial sensing, ventricular sensing and pacing pacemaker
  • Dual chamber rate responsive pacemaker
  • Dual chamber pacemaker

On September 22, 2005, Guidant initiated a recall on several pacemaker models in the following groups of pacemakers:

  • INSIGNIA I Ultra
  • INSIGNIA I Entra
  • NEXUS I Plus
  • NEXUS I Ultra
  • NEXUS Entra

On July 15, 2005, Guidant recalled a series of specific pacemaker models; this FDA news release provides more details on this recall. The following were models included in this recall:

  • PULSAR® MAX Models 1170, 1171, 1270
  • PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
  • DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
  • MERIDIAN® Models 0476, 0976, 1176, 1276
  • PULSAR MAX II Models 1180, 1181, 1280
  • DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  • CONTAK TR® Model 1241
  • VIRTUS PLUS® II Models 1380, 1480 (models only available outside the United States)
  • INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499 (models only available outside the United States)

Patients who suffer injuries before a defective pacemaker has been taken out of use may have a claim for damages against liable parties, such as manufacturers like Guidant or Medtronic.

If you or loved one has experienced health problems after having a pacemaker implanted, it is possible that the pacemaker has caused an injury. If you are faced with the possibility that a pacemaker has caused an injury to you or a loved one, contact Anderson Law Offices, LLC to protect your rights and interests, and to receive a free initial consultation on your case.

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Anderson Law Offices, LLC 17138 Lorain Avenue, Suite 211 | Cleveland, OH 44111
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