Medtronic Spine: Misplacement of Infuse study showing adverse effects not intentional — 7 key notes

Written by Anuja Vaidya | May 19, 2016 | Print  |

Medtronic Spine President Douglas King wrote U.S. senators a letter stating the misplacement of data on its Infuse product was not intentional, according to a Minneapolis Star Tribune report.

Here are seven key notes:

 

1. Sens. Al Franken (D-Minn.) and Amy Klobuchar (D-Minn.) requested further information from the medical device giant after Star Tribune published a report on Medtronic's Infuse studies on April 10. The report examined the FDA studies and lawsuits against the company. 

 

2. The FDA granted approval to the Infuse product in 2002, but the agency did not receive all the data on adverse events.

 

3. Medtronic allegedly misplaced a study of 3,647 Infuse patient records that revealed 1,045 "adverse events."

 

4. The company said that reporting problem occurred because "Medtronic Spine's policies for reporting patient injuries in such a study were unclear, the department did not have a master list of its clinical activities, and the study was closed down without following a formal process," noted the Star Tribune.

 

5. The letter from Medtronic also stated "we have no information to suggest the failure to report was intentional," according to the report.

 

6. Sen. Franken has said while he welcomes the new information from Medtronic, he still has questions.

 

7. In a statement to the Star Tribune, Medtronic stated it stands by Infuse and more than a million patients have safely used the product.

 

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