PRODUCT ADVISORIES Sacral Neuromodulation

InterStim System Advisory Archive

Medtronic is committed to providing you with the highest quality products and services and ongoing support.

As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.


2019

URGENT: MEDICAL DEVICE CORRECTION – MAY 2019

Pelvic Health InterStim™ THERAPY: IMPORTANT INFORMATION REGARDING THE A510 CLINICAN APPLICATION (on Medtronic’s smart programmer)

Models Affected: A510 Clinician Application (on Medtronic’s smart programmer)

Description:

This letter is to notify you of the potential for an unexpected increase in stimulation during InterStim programming with the A510 Clinician Application (on Medtronic’s smart programmer). The issue occurs when enabling a new program on an InterStim implantable neurostimulator (INS) with the A510 Clinician Application if the InterStim INS has previously been interrogated or programmed with an N’Vision ™ Clinician programmer (8840). This issue may occur during device programming, which is performed by the healthcare professional in a clinical setting. Included in this notification are steps that can be taken on the A510 Clinician Application (on Medtronic’s smart programmer) to prevent the issue.

Read on for detailed information related to this communication.