| Copyright (c) 2008 Katie Kelley | | | | implantable cardioverter-defibrillators which had |
| A process in correcting a condition known as | | | | been linked to four deaths and a serious injury. A |
| abnormal heart rhythm (arrhythmia) is when an | | | | high majority of the Micro Jewel II Model 7223Cx |
| implantable cardiovert defibrillator (ICD) is surgically | | | | and the GEM DR Model 7271 ICDs, which were |
| implanted into the chest. The ICD monitors and | | | | affected by the recall, were implanted from 1997 |
| corrects episodes of arrhythmia among patients. | | | | to 1998. It is believed that 1,800 units may have |
| ICDs can generate (1) a series of precisely timed | | | | been in use during that time period. |
| low-intensity electrical pulses to reset the heart to | | | | On February 11, 2005, the Food and Drug |
| normal rhythm when the heartbeat becomes | | | | Administration (FDA) announced that Medtronic |
| faster than normal (ventricular tachycardia), and | | | | was recalling certain ICDs due to a battery |
| (2) electric shocks that may feel like a sudden | | | | shorting defect which results in rapid battery |
| kick in the chest to stop potentially fatal quivering | | | | depletion leading to loss of device function. |
| of the heart (ventricular fibrillation). | | | | Devices with batteries manufactured between |
| In addition, the ICD may be programmed to work | | | | April 2001 and December 2003 may exhibit this |
| as a pacemaker and send small electrical signals to | | | | shorting action. Medtronic then announced in |
| pace the heart whenever it detects an abnormally | | | | February 2005 that their ICDs and cardiac |
| low heartbeat (bradycardia). | | | | resynchronization therapy defibrillators (CRT-Ds) |
| These electronic medical devices are placed in the | | | | may have battery shorts. |
| body to prevent cardiac arrest from severe | | | | Defibrillators which are affected include: Marquis |
| ventricular tachycardia. The defibrillator works by | | | | VR/DR Iand Maximo VR/DR ICDs and the InSync |
| connecting a small electrode between the heart | | | | I/II/III Marquis and InSync III Protect CRT-D |
| and a computer in the device. This device | | | | lines, manufactured between April 2001 and |
| monitors the heartbeat and if it detects an | | | | December 2003. CRT-Ds are implantable devices |
| arrhythmia, it activates a built-in pacemaker to | | | | used to treat heart failure and other |
| stabilize the heart rate. If this fails, the defibrillator | | | | life-threatening heart rhythm disturbances by |
| sends a jolt to the heart. ICDs are among the | | | | delivering electrical impulses to the heart. |
| fastest-growing group of medical devices; in the | | | | On June 21, 2005, the FDA criticized Medtronic's |
| year 2005 alone, more than 200,000 patients are | | | | procedures for following up on complaints about |
| expected to have one implanted. | | | | an external defibrillator, including a failure to |
| An ICD can cost up to $25,000 for the device | | | | properly investigate a patient's death. This letter |
| itself and uncomplicated hospital and doctor costs | | | | focused on damaged cable connectors in the |
| can run another $15,000 to $25,000. | | | | devices, which are designed to deliver a powerful |
| Unfortunately, the results can be fatal if a device | | | | shock to patients experiencing sudden cardiac |
| is damaged or defected. It is believed that the | | | | arrest. However, cables that are damaged or |
| Medtronic defibrillators allegedly knew of the | | | | have defects will send the wrong amount of |
| defects prior to being sold and implanted into | | | | power. The problems highlighted in the letter "may |
| thousands of patients. Medtronic has recalled | | | | be symptomatic of serious problems in your |
| approximately 65,000 defective devices. Defects | | | | firm's manufacturing and quality assurance |
| in Medtronic devices include internal short circuits, | | | | systems." |
| memory errors, and problems with magnetic | | | | FDA Warning |
| switching. Ventricular tachycardia or fibrillation | | | | The FDA has advised patients to take the |
| occurs when rapid, and fatal, threatening | | | | following steps: |
| arrhythmias occur in the heart's lower chambers; | | | | * Contact your doctor to determine if you have |
| ICDs shock the heart into normal rhythm when | | | | an affected ICD. |
| this occurs. Some of the defibrillators failed to | | | | * Contact your doctor if you feel an electrical |
| charge properly, resulting in late or non-delivery of | | | | shock from your device. |
| cardiac shock therapy. | | | | * Contact your doctor or go to the nearest |
| FDA Recalls Defective Medtronic ICDs | | | | emergency room if you hear an audible "beeping" |
| In April 2004, Medtronic announced a recall of two | | | | from your ICD. |