Guidant Safety Warnings

 

 

 

In this section:

• Boston Scientific Recall
• Guidant Products
• Guidant Safety Warnings
• Guidant FDA Recall

The Guidant Corporation is involved in the development and manufacture of cardiovascular medical devices that are used in the treatment of various abnormal heart defects: bradyarrhythmias, tachyarrhythmias, atrial fibrillation and heart failure.

When it comes to manufactured devices, defects are always a possibility. Defects can be the result of an anomaly affecting a single device, or the result of negligence, affecting a large number of devices. Widespread defects typically affect a particular grouping of devices. Such widespread defects do not always warrant the issuing of a recall.

A recent Guidant pacemaker recall (June 17th, 2005) has generated a great deal of media attention because it affects a variety of Guidant’s cardiovascular medical devices, notably their ICD and CRT devices. The Food and Drug Administration (FDA) classified Guidant recall has led a number of patients with defective Guidant pacemakers to seek legal assistance. Those injured as a result of being implanted with a Defective Guidant pacemaker may be eligible to receive compensation for any medical expenses, loss of income or pain and suffering costs.

The following advisories represent a mere handful of the safety warnings issued by the Guidant Corporation over the years.

Guidant Pacemaker Safety Warnings

Pulsar, Discovery, Meridian, Contak, Virtus and Intelis Devices

January 21st, 2006 – Guidant’s most recent pacemaker safety advisory was in regards to certain Guidant pacemaker devices that were manufactured between October 27th, 1997 and December 5th, 2000. A widespread defect was discovered in which an unacceptable amount of moisture was able to enter the pacemaker case. The leaking was judged to be the result of the gradual degrading of a seal used in the Guidant devices. The defect has thus far presented itself in 150 devices out of a total of 131,500. Several of the 150 failures led to patients losing consciousness or facing increased risk of heart failure; however, no deaths have resulted from the defect.

Insignia Devices

October 3rd, 2005 – Guidant issued a safety advisory for its Insignia pacemakers, reporting minor problems that some patients have experienced. In response to Insignia patients’ reports of dizziness, lightheadedness and episodes of fainting (requiring hospitalization), Guidant notified the FDA and physicians of the possibility of Insignia patients experiencing similar symptoms; however, Guidant expects the defect to affect less than .1% of all Insignia products.

Guidant Implantable Cardioverter Defibrillator Safety Warnings

Guidant Ventak Prizm 2 DR Model 1861

December 20th, 2005 – Guidant were forced to issue a safety advisory for Ventak ICDs that were manufactured prior to April 16, 2002. A defect was detected that caused an internal short in the device, limiting its capacity to function appropriately. When defibrillation is required, the defect could prevent the ICD from delivering enough of a shock to correct a patient’s abnormal heart rhythm. Of the 32 reported defective devices (out of 11,000 implanted devices), the issue has been associated with two deaths. The failure rate has not yet reached a level that Guidant feel it necessary to issue a recall; however, they strongly suggest that patients implanted with a Ventak Prizm ICD continue to visit their physician regularly to ensure that the device continues to function properly.

Guidant Cardiac Resynchronization Therapy Safety Warnings

Contak Renewal (H135) and Contak Renewal 2 (H155)

December 20th, 2005 – A Guidant safety advisory was issued for two of the Contak Renewal CRT series because of a defect that was causing an internal short that prevented the devices from functioning appropriately (The same problem as the Ventak Prizm ICD devices). Of the 16,000 implanted Contak devices, Guidant reported 35 instances of device failure, five of which resulted in death. Guidant advises all patients with Contak Renewal CRT implants to visit their physician regularly to ensure that the device continues to function properly.

Contak Renewal 3RF / RF HE and Contak Renewal 4RF / RF HE

March 11th, 2006 – A Guidant safety advisory was issued for certain Contak Renewal cardiac resynchronization therapy devices, including:

• Contak Renewal 3 RF (Models H210 & H215) & Contak Renewal 3 RF HE (Models H217 & H219)
• Contak Renewal 4 RF (Models H230 & H235) & Contak Renewal 4 RF HE (Model H239)

Guidant received 39 documented reports of lower than expected battery voltage for devices prior to implant. All such defective devices were not implanted. Of the 4,000 devices implanted worldwide, Guidant has not yet received any reports related to lower than expected battery voltage. Guidant recommends that patients implanted with one of the aforementioned devices continue their routine check-ups with their doctors where they can discuss any updates related to the battery voltage defect.

In March of 2007, the UK Medicines and Healthcare Products Regulatory Agency issued an advisory update to the FDA advisory that spanned March of 2004 to January of 2007. This most recent advisory was issued in regards to a “charge time” defect affecting some implantable heart devices that could potentially cause a delay in their ability to deliver necessary shocks. While some devices have been replaced as a result of the defect, there have been no injuries reported as a result.