Device product
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Z-1572-2014
Product summary
- Event
- Event 67921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34
- Official record key
device-enforcement:Z-1572-2014
Official wording
Reason: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Code information: Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z
Distribution pattern: Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
Derived failure modes
-
Unknown
A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.