MAUDE Adverse Event Report: MEDTRONIC INC. INTERSTIM NEUROSTIMULATOR MODEL 3057; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3057

Device Problems Break (1069); Entrapment of Device (1212); Defective Component (2292)

Patient Problems Failure of Implant (1924); Undesired Nerve Stimulation (1980); Brain Injury (2219); Nervous System Injury (2689); Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2015

Event Type  Injury  

Event Description

Re: medtronic interstim neurostimulator device model 3057.I have been a medtronic interstim neurostimulator implant patient since 2009.My first interstim was the 3057 implanted in 2009 by dr (b)(6) in (b)(6) and the device performed very well.When the battery came to the end of its life, a replacement 3057 battery pack was inserted in 2014 by dr (b)(6) of (b)(6).Soon after that surgery i developed what seemed like electric shocks or short circuits in the vaginal/rectal area and an urgent replacement 3057 surgery had to be carried out in (b)(6) 2015 by dr (b)(6) of (b)(6) (as dr (b)(6) was 'on vacation' and my situation was urgent).Post-surgery, dr (b)(6) informed me that a broken lead was inside me as he was unable to remove it.This was the first i had heard of any issue with a lead having broken or have any notice that a lead could actually break off! nobody at medtronic nor my surgeons had even mooted that this could be a possibility.The medtronic rep who was present during this particular procedure never told me afterwards ¿ not a word.Isn't medtronic supposed to alert its patients and the fda of any adverse situation involving devices that break inside the patient? moving to (b)(6) in 2016 i came under the care of dr (b)(6) who has been in charge of my medtronic neurostimulator care and surgeries since then.After my latest device came to the end of its battery life in (b)(6) 2021, dr (b)(6) implanted the latest model (the rechargeable interstim 97810) which is mri compliant (unfortunately this device is also defective and i will be making a report about this separately to you).After this last surgery ((b)(6) 2021) dr (b)(6) said that he could "see the tip" of the broken lead but it was too deep to be removed by him safely.Due to a spinal and brain injury in 2021, i have been in need of mris, but due to the defective neurostimulator medtronic inserted and which broke off and is still inside me - i am unable to have mris.This has been my first opportunity to report this particular device as i didn't know prior to today that i would be able to report the adverse effect.Medtronic never alerted me to the fact that the device had the potential to break inside the patient, never acknowledged that i had an issue with the device and, indeed, never communicated with me at any time about the 3057 broken lead.Due to the defective product, i have been left without the option to have medical procedures that are available to others.I also underwent replacement surgery, but the abandoned lead could not be recovered and is still inside me.Fda safety report id #(b)(4).

• Brand Name: INTERSTIM NEUROSTIMULATOR MODEL 3057
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 15470342
• MDR Text Key: 300649805
• Report Number: MW5112219
• 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: 09/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 3057
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2022
• Patient Sequence Number: 1
• Treatment: VIIBRYD 40 MG, 20 MG BELSOMRA, QULIPTA.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White