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Interstim percutaneous extension
Official notice
24 Jan 2022
Last checked
24 Jan 2022
An official Health Canada notice concerns Interstim percutaneous extension. Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the percutaneous extension connector after the evaluation period when it is necessary to remove the percutaneous extension and external neurostimulator (ENS). In some cases of reported migration, an additional incision along the tunneling pathway has been required to disconnect the lead from the percutaneous extension. Patients may also be at an increased risk of procedural complications due to delays associated with troubleshooting. Additionally, if the chronic lead is damaged or displaced during the explant of the percutaneous extension, intraoperative replacement of the lead or an additional surgical procedure may be needed. Recall start date: Mar 10, 2021 Published 2022-01-24.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63862
Official notice
2022-01-24
The hazard
The hazard
Medtronic has identified eighteen reports where during the advanced evaluation trial period, the percutaneous extension connector has migrated from the future stimulator pocket site along the tunneling pathway. This resulted in difficulty locating the percutaneous extension connector after the evaluation period when it is necessary to remove the percutaneous extension and external neurostimulator (ENS). In some cases of reported migration, an additional incision along the tunneling pathway has been required to disconnect the lead from the percutaneous extension. Patients may also be at an increased risk of procedural complications due to delays associated with troubleshooting. Additionally, if the chronic lead is damaged or displaced during the explant of the percutaneous extension, intraoperative replacement of the lead or an additional surgical procedure may be needed. Recall start date: Mar 10, 2021
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Medtronic, Interstim Percutaneous Extension.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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