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

Patient Problems Cellulitis (1768); Swelling (2091); Implant Pain (4561)

Event Date 06/09/2023

Event Type  Injury  

Event Description

Had interstim device from medtronic implanted (b)(6) 2022 for oab (overactive bladder), the same week developed cellulitis and was on antibiotics for 10 days.Device wasn't really effective but better than nothing.Had no further issues until (b)(6) 2023 when i had pain and swelling to implantation site.I went to my doctor's office and said i wanted device removed(was on 3 antibiotics for 2 weeks)and had surgery on (b)(6) 2023.I regret ever having this device.In general the er (emergency room) visit on (b)(6) 2023 showed infection and i was prescribed keflex.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 17463311
• MDR Text Key: 320563219
• Report Number: MW5120603
• 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: Patient
• Type of Report: Initial
• Report Date: 08/01/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Patient Sequence Number: 1
• Treatment: KEFLEX.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American