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Unnecessary Medical Defibrillators Fail Causing Severe Injury

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San Jose defective medical device attorney, cardiac defibrillators recalled,  heart attack patient, defective medical device, medical device recallCardiac defibrillators are life-saving devices for many individuals who have no other alternative. Implantable defibrillators work similarly to Automated External Defibrillators (AED) which aid in CPR and other rescue procedures. When a patient’s heart rate begins pulsing at a low and unhealthy rate, the implanted device delivers a shock to the heart, forcing it back into a regular rhythm.

Studies show that nearly 100,000 patients undergo the $35,000 procedure annually and that a large percentage of these were unnecessary. Unfortunately, many of these devices were also recalled, yet doctor’s continued to utilize the malfunctioning equipment.

Unnecessary Risk

For those patients who genuinely need the devices, this is a life-changing solution. For the 22 percent of recipients who received the implant unnecessarily, the surgeon recklessly endangered their lives, potentially more than once.

In a study funded by the National Heart, Lung, and Blood Institute, guidelines regulating the necessity and effectiveness of a defibrillator are being blatantly ignored. For example, two separate randomized studies conclusively show that defibrillators are ineffective for patients who suffered a heart attack, yet many physicians recommend the device after a cardiac episode.

When the devices are implanted unnecessarily, the patient is at undue risk for the following:

  • Unnecessary and unexpected pulses;
  • Heart damage from frequent shocks;
  • Surgery risks;
  • Higher risk of heart failure; and
  • Device malfunctions.

St. Jude and Guidant Recalls

With the hefty price tag, there is no wonder why doctor’s continue utilizing questionable instruments even after a recall. Not only is the initial payout nice, but defibrillators run on a lithium battery which runs out generally somewhere between four and 10 years. Even if the patient never needs a “jolt,” the theory that “it is better to be safe than sorry” fits, right? Not necessarily, because some of these devices often do more harm than good.

The Prizm 2, manufactured by Guidant in the early 2000’s, was known to experience electrical failure causing cardiac arrest, yet the model continued earning market sales. Boston Scientific later purchased Guidant.

St. Jude Medical, another well-known medical instrument brand, also underwent a name-change after recalling Fortify, Unify, and Assura model ICDs and CRT-Ds last year due to reports of rapid battery failure. Lithium deposits within the battery built up causing a short circuit. St. Jude is now Abbott.

When Medical Help Fails, Get Legal Backup

If you received a defibrillator unnecessarily after a heart attack, or if your device failed, you may be owed financial compensation for your experience. The attorney’s at Corsiglia McMahon & Allard, L.L.P. will carefully assess your case, identify all of the responsible parties and hold them accountable for their carelessness. Our lawyers understand that the cost of the device alone is staggering, let alone the associated medical expenses, loss of income from days missed, and the pain and suffering you endured. A San Jose, CA defective medical device attorney can help you explore the available options. Call 408-289-1417 now to schedule your free, no-obligation appointment.

Source:

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526317.htm

https://www.nytimes.com/2011/01/05/health/05device.html

https://www.cbsnews.com/news/boston-scientific-gets-guidant/

https://www.sjm.com/en/patients/arrhythmias/our-solutions/icds?clset=af584191-45c9-4201-8740-5409f4cf8bdd%3ab20716c1-c2a6-4e4c-844b-d0dd6899eb3a

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