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. 2023 Jan;25(1):150-155.
doi: 10.1111/codi.16370. Epub 2022 Oct 29.

Replacement Adaptor 09106 for patients with a dynamic graciloplasty or patients with sacral neuromodulation and abdominal implantable pulse generators: a retrospective, single centre, Stage 2a/2b development IDEAL case series

Roman Assmann  1   2 , Perla Douven  2   3   4 , Elbert A Joosten  2   4 , Gommert A van Koeveringe  2   3 , Stephanie O Breukink  1   2   5   6 , Jarno Melenhorst  1   6
Affiliations

Replacement Adaptor 09106 for patients with a dynamic graciloplasty or patients with sacral neuromodulation and abdominal implantable pulse generators: a retrospective, single centre, Stage 2a/2b development IDEAL case series

Roman Assmann et al. Colorectal Dis. 2023 Jan.

Abstract

Aim: Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs.

Methods: Seventeen patients (11 women, six men) received a replacement adaptor with a follow-up of 6 months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien-Dindo classification.

Results: Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien-Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien-Dindo Grade II) and one patient had persisting pocket pain (Clavien-Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test.

Conclusion: The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.

Keywords: adaptor; dynamic graciloplasty; faecal incontinence; neuromodulation; neurostimulation.

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Conflict of interest statement

Assmann: unrestricted research grant from Medtronic. Douven: nothing to declare. Joosten: nothing to declare. Van Koeveringe: clinical trial support from Medtronic, consultant and surgical proctor to Boston Scientific, consultancy Solace Therapeutics, clinical trial support Minze Health. Breukink: unrestricted research grant from Medtronic. Melenhorst: unrestricted research grant from Medtronic.

Figures

FIGURE 1
FIGURE 1
(A) Itrell‐II; (B) Interstim I; (C) Interstim II; (D) Connection piece to connect single SNM lead to two Interstim I access points
FIGURE 2
FIGURE 2
Replacement adaptor 09106
See this image and copyright information in PMC

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