MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

High, r.A., winkelman, w., panza, j., sanderson, d.J., yuen, h., halder, g., shaver, c., bird, e.T., rogers, r.G., danford, j.M.Sacral neuromodulation for overactive bladder in women: do age and comorbidities make a difference? int urogynecol j.2020.Doi: 1 0.1007/s00192-020-04392-4.Summary: to evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder.Methods this multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation.The primary outcome was progression to implantation.A sub-analysis of implanted patients was performed for the outcome of additional therapies or ¿implant only¿ for the duration of follow-up.Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed.Results at six academic institutions, 91% (785/864) of patients progressed to implantation.Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years.Odds of implantation [or 0.73 (ci 0.61, 0.88)] and post-implantation success [or 0.78 (ci 0.98, 0.97)] were lower with increasing decades of age.Medical comorbidities evaluated did not affect implantation rates or post-implant success.Conclusions most women have successful sacral neuromodulation trials despite older age and comorbidities.Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation.Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation.Most women add therapies to improve efficacy post-implantation, and explantation rates are low.Reported events: most patients kept the implant while adding therapies: 63/248 (25%) had device explantation.Despite the need to add therapies after implantation, most patients in our study elected to keep their ipg.The study method does not account for revisions: it is possible that the older patients added therapies while younger patients progressed to surgical intervention of revisions.Further studies are needed to investigate differences in postimplantation symptom management by patient age.No specific device information provided.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10819484
• MDR Text Key: 217692683
• Report Number: 2182207-2020-01253
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention