Medtronic Approved for Sale of Quattro Lead in Japan

Search

Topics

Uncategorized

Links
- FDA

Case Review Form

* Denotes required field.

Title

* First Name

* Last Name

* Email Address

* Phone Number

Cell Phone Number

Office Phone Number

Street Address

Apartment/Suite

City

State

Zip Code

Please provide the best method and times to contact you:

Date of birth of injured person
(mm-dd-yyyy):

Name of medical device:

Please describe any problems or injuries caused by the device:

Other Info:

No Yes, I agree to the Parker & Waichman, LLP disclaimers.Click here to review all.

Yes, I would like to receive the Parker & Waichman, LLP monthly newsletter, InjuryAlert.

Archives

Latest Medical Device News

20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP - Recall of one lot due to possible incorrect bar code for 5% Dextrose Injection, USP. The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication.
Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences - Recall issued because the devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
Greenline-D MacIntosh No. 3 Laryngoscope Blades - Class 1 recall due to potential for piece of blade to break off during procedure.
Healon D Ophthalmic Viscosurgical Device - Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.
Hydromorphone HCl 2 mg Tablets - Nationwide recall of a single lot due to potential for oversized tablets.
Innohep (tinzaparin sodium injection) - [UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency
October 2008 Safety Labeling Changes - Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) - Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products.
Stryker Custom Cranial Implant Kits - Class 1 recall because sterility cannot be assured.
Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae - Worldwide recall involving 21 lot codes, due to reports of difficulty retracting the introducer from the cannula.
Weight Loss Pills - Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.

Medtronic Approved for Sale of Quattro Lead in Japan

December 19th, 2007 amy

Medtronic, the company whose recently recalled Sprint Fidelis leads have killed five people and injured many more, has been approved to sell its Sprint Quattro leads in Japan. The Quattro lead has been in use in the U.S. and in Europe since 2001. Although many doctors had been using the Fidelis leads for their smaller wire diameters, they fell back to using the Quattro leads after the Fidelis leads were recalled.

Medtronic faces multiple lawsuits in the U.S. for patients whose Fidelis leads fractured, as well as lawsuits from those whose defibrillator lead wires haven’t fractured yet but live in fear of the day they will. The dangerously thin wires, when fractured, have caused multiple severe shocks to patients which have killed some people and severely injured others. The fractured leads in other cases have caused the defibrillators to stop sending lifesaving shocks to the patient altogether, resulting in more deaths and dangerous complications.

Share and Enjoy: These icons link to social bookmarking sites where readers can share and discover new web pages.