Time to Mechanical Malfunction (144 limited adverse events reported)
- <=1 year: 19%
- 2-5 years: 39%
- 6-10 years: 31%
- 11-15 years: 7%
- 16-20 years: 3%
- 20-25 years: 1%
Max: 21 years (CONGRATULATIONS!)
Median: 4 years
Time to Mechanical Malfunction due to Tubing Fracture alone
- <=1 year: 14%
- 2-5 years: 42%
- 6-10 years: 33%
- 11-15 years: 6%
- 16-20 years: 3%
- 20-25 years: 3%
Max: 21 years
Median: 5 years
Source: FDA MAUDE Database
Disclaimer
The MAUDE database contains reports of adverse events involving medical devices submitted to the FDA. A submitted report does not necessarily reflect a conclusion by the FDA or the reporter that the device caused or contributed to the event. Reports may be incomplete, inaccurate, unverified, or biased and have not been evaluated by the FDA. MAUDE data cannot be used to determine event rates or to compare safety between devices.
