INTRODUCTION: Explantation of the Interstim sacral neuromodulation (SNM) device is occasionally necessary. Removing the tined lead can put strain on the lead, resulting in a possible break and retained fragments. The Food and Drug Administration (FDA) released a notification regarding health consequences related to retained lead fragments. We describe a novel and safe surgical technique for removing the Interstim device and permanent lead. MATERIALS AND METHODS: We searched the Manufacturer and User Facility Device Experience (MAUDE) database for complications related to tined lead removal and searched the database of a single surgeon at our institution. Our standardized technique for tined lead removal is as follows. An incision is made over the previous lead insertion site and the lead is isolated and externalized. The fibrous encapsulation is dissected off the lead to expose the tines and ensure the lead is free from adhesions. The lead is removed by wrapping it around a curved hemostat and turning it under tension. If the lead breaks, the incision is extended and dissection is carried down to the sacral body to remove all fragments. RESULTS: Twenty-eight patients had their tined lead removed between 2009 and 2015 after being in place a median of 2.00 years (IQR 1.32-3.32 years). One lead broke (3.6%) during removal over the 6 years using our standardized approach. CONCLUSION: Permanent tined leads can break on removal and retained fragments can pose significant health consequences. Our technique standardizes the approach for removal and is safe and effective in our series.
INTRODUCTION: Explantation of the Interstim sacral neuromodulation (SNM) device is occasionally necessary. Removing the tined lead can put strain on the lead, resulting in a possible break and retained fragments. The Food and Drug Administration (FDA) released a notification regarding health consequences related to retained lead fragments. We describe a novel and safe surgical technique for removing the Interstim device and permanent lead. MATERIALS AND METHODS: We searched the Manufacturer and User Facility Device Experience (MAUDE) database for complications related to tined lead removal and searched the database of a single surgeon at our institution. Our standardized technique for tined lead removal is as follows. An incision is made over the previous lead insertion site and the lead is isolated and externalized. The fibrous encapsulation is dissected off the lead to expose the tines and ensure the lead is free from adhesions. The lead is removed by wrapping it around a curved hemostat and turning it under tension. If the lead breaks, the incision is extended and dissection is carried down to the sacral body to remove all fragments. RESULTS: Twenty-eight patients had their tined lead removed between 2009 and 2015 after being in place a median of 2.00 years (IQR 1.32-3.32 years). One lead broke (3.6%) during removal over the 6 years using our standardized approach. CONCLUSION: Permanent tined leads can break on removal and retained fragments can pose significant health consequences. Our technique standardizes the approach for removal and is safe and effective in our series.
Authors: Neel H Patel; Nikil Uppaluri; Michael Iorga; Ariel Schulman; Jonathan B Bloom; John Phillips; Sean Fullerton; Sensuke Konno; Muhammad Choudhury; Majid Eshghi Journal: J Endourol Date: 2019-05-24 Impact factor: 2.942
Authors: Marcelo Mass-Lindenbaum; D Calderón-Pollak; H B Goldman; Javier Pizarro-Berdichevsky Journal: Int Braz J Urol Date: 2021 May-Jun Impact factor: 1.541