Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_0
FDA device recall Z-0037-2008 · posted 2007-10-11 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- Reason for recall
- A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .
- Action taken
- Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.
- Root cause
- Software design
- Status
- Terminated
- Product code
- EZW
- Quantity affected
- 1885
- Distribution
- Nationwide and the Netherlands.
- Date initiated
- 2007-06-25
- Date posted
- 2007-10-11
- Date terminated
- 2010-10-08
- Location
- Minneapolis, MN
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