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

Model Number 3889-28

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

Patient Problems Inflammation (1932); Pain (1994); Weakness (2145); Discomfort (2330)

Event Date 01/06/2019

Event Type  Injury  

Event Description

Pt underwent an implantation of an interstim neuromodulation device into the left s3 foramen for overactive bladder on (b)(6) 2018.She recovered without event.She had good response to device with improvement of urinary incontinence.She was admitted on (b)(6) 2019 with sudden lower back pain, bilateral leg discomfort and leg weakness.Interstim was removed at request of neurology to allow for mri.Mri showed inflammation from t12 to l2 and given diagnosis of transverse myelitis.She was treated with iv antibiotics.Pain and weakness improved pod #1.Fda safety report id# (b)(4).

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8550162
• MDR Text Key: 143285203
• Report Number: MW5086161
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2019

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: Lay User/Patient
• Device Expiration Date: 10/19/2021
• Device Model Number: 3889-28
• Device Lot Number: VA1L3XC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 89