MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number NEU_INTERSTIM_INS

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

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Parker-autry, c.Y., bauer, s., ford, c., gregory, w.T., badlani, g., scales, c.D.(2024).Examining the role of frailty on treatment patterns and complications among older women undergoing procedure-based treatment for urinary incontinence.The gerontological society of  america.2024:glae027.Doi:10.1093/gerona/glae027 a.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Parker-autry, c.Y., bauer, s., ford, c., gregory, w.T., badlani, g., scales, c.D.(2024).Examining the role of frailty on treatment patterns and complications among older women undergoing procedure-based treatment for urinary incontinence.The gerontological society of  america.2024:glae027.Doi:10.1093/gerona/glae027 summary: the background is with aging beyond 65 years is associated with increased prevalence of urinary incontinence (ui), frailty, and incr eased complication rate with ui treatments.To investigatethis relationship, we examined frailty as a predictor of procedure-based ui treatment patterns and urologic complications in medicare-eligible women.The methods used was identification of women undergoing procedures for ui between 2011-2018 in the 5% limited medicare data set.A claims-based frailty index (cfi) using data from the 12-months prior to the index procedure defined frailty (cfi=0.25).Urologic complications were assessed during the 12-months following the index procedure.We used unadjusted logistic regression models to calculate odds of having a specific type of ui procedure based on frailty status.Odds of post-procedure urologic complications were examined with logistic regression adjusted for age and race.As a result, it was identified 21,783 women who underwent a procedure-based intervention for ui, of whom 3,826 (17.5%) were frail.Frail women with stress ui were 2.6 times more likely to receive periurethral bulking (95%ci 2.26-2.95), compared to non-frail.Conversely, frailty was associated with lower odds of receiving a sling or burch colposuspension.Among women with urgency ui or overactive bladder (oab), compared to non-frail, frailty was associated with higher odds of both sacral neuromodulation (or=1.21, 95%ci 1.11-1.33) and intravesical botox (or=1.16, 95%ci 1.06-1.28), but lower odds of receiving posterior tibial nerve stimulation.Frailty was associated with higher odds of post-procedure urologic complications (or=1.64, 95%ci 1.47-1.81).In conclusions, frailty status may influence treatment choice for treatment of stress or urgency ui symptoms and increase the odds of post-procedural complications in older women.Reported event: 1.       there was report of post-procedure urologic complications.Urologic complication was defined as an icd-9 or icd-10 code consistent with: a new diagnosis of urgency ui, urinary tract infection, voiding dysfunction, urinary retention, bladder trauma, overflow incontinence, slowing urinary stream, genital pain/dyspareunia.See attached literature article.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19191397
• MDR Text Key: 341165565
• Report Number: 2182207-2024-02410
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• 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): Other
• Patient Sex: Female