MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSTIM SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 978B128

Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

Patient underwent medtronic interstim placement for treatment of urinary & fecal incontinence.The interstim stage 1 lead placement was completed without complication.On pod #2 (post operative day), the patient (pt) reported irritation & redness at the surgical site.It was thought to be a reaction to bandage and pt was instructed to use paper tape.Patient also reported feeling tongue swelling but no difficulty breathing/swallowing noted.No further s/s (signs or symptoms) of reaction noted.The next stage was completed without complication - interstim stage 2 insertion of peripheral neurostimulator pulse generator & electronic analysis of implanted neurostimulator pulse generator system.Following stage 2 of the procedure, the patient had signs/symptoms concerning for infection at the surgical site (tenderness, sore, redness, & weeping).Cultures were collected.The patient was treated with antibiotics but failed to improve.The site worsened, progressing to dehiscence of the wound, and the interstim device had to be removed.The surgeon noted concerns for infection and inflammatory process.It has been noted the patient has an allergy to nickel.This device is reportedly nickel-free, but the surgical team noted a concern for possible allergic reaction.Manufacturer response for neurostimulator, interstim surescan lead (per site reporter).The company rep has requested the device for it to be evaluated by the company.

• Brand Name: INTERSTIM SURESCAN
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 18985630
• MDR Text Key: 338686789
• Report Number: 18985630
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 978B128
• Device Lot Number: VA2UY1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 91 KG