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