Company: Medtronic Neurological,
Date of Enforcement Report:10/17/2007
Class:ll
PRODUCT
Medtronic InterStim II INS Model 3058 with N’Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N’Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008
REASON
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 .
RECALLING FIRM/MANUFACTURER
IMedtronic Neurological, Minneapolis, MN, by letter beginning on July 11, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,885 units
DISTRIBUTION
Nationwide and the Netherlands