Medtronic issues safety notice for InterStim SureScan MRI ... | 合法醫療器材資訊網
2020年10月23日—basedMedtronicsaidinthenoticeoutofGermanythattheMedtronicModel3560030/3560022percutaneousextensionisintendedforusewith ...
Medtronic[1] (NYSE:MDT[2]) recently issued an urgent field safety notice to alert users to a potential issue with its InterStim SureScan MRI leads.
Fridley, Minn.-based Medtronic said[3] in the notice out of Germany that the Medtronic Model 3560030/3560022 percutaneous extension is intended for use with the Model 978A1/978B1 InterStim SureScan MRI leads during an advanced evaluation to screen potential candidates for chronic sacral neuromodulation therapy.
The company has identified 18 reports in which, during that evaluation period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway, which resulted in difficulty locating the connector when it is necessary to remove the extension and external neurostimulator.
In some reported cases, an additional incision along the tunneling pathway was required to disconnec...
EXT 3560022 ISTM QUAD PERC 4.32MM Medical Device ... | 合法醫療器材資訊網
InterStim Micro (neurostimulator) | 合法醫療器材資訊網
InterStim™ (00763000203894) | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
Medtronic issues safety notice for InterStim SureScan MRI ... | 合法醫療器材資訊網
Sacral Neuromodulation Systems | 合法醫療器材資訊網
Sacral Neuromodulation Systems | 合法醫療器材資訊網
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