Device product
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Z-1691-2013
Product summary
- Event
- Event 65420
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5 US and and 360 OUS
- Official record key
device-enforcement:Z-1691-2013
Official wording
Reason: Miscalibrated Fill Level Sensor may affect dosing level
Code information: All serial numbers
Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.
Derived failure modes
-
Unknown
Miscalibrated Fill Level Sensor may affect dosing level