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

Model Number 3058

Device Problems Break (1069); Electromagnetic Interference (1194); Energy Output Problem (1431); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330); Numbness (2415); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction (incontinence, urgency, and/or frequency).It was reported that the patient had a fractured, damaged, or broken lead.They turned patient device off to ensure patient was in no pain.P was on program 1 at 2.8 volts.After turning the device off, they turned the device back on at a very low and comfortable amplitude, 0.2, to check the lead.All 4 electrodes were orange and showed impedances.The patient also stated having shock from device. patient stated device ¿shocks¿ her when going through a metal detector and has happened before but could not remember when and did not report it.The patient's fiancé stated (b)(6) 2022 was the first time it happened.Shocking ¿dropped her to her knees from the pain¿ and resulted in er visit until device was turned off.The patient reported pain, discomfort/soreness/pinching/ache/pressure.The device was turned off.The issue was resolved.

Manufacturer Narrative

Concomitant medical products: product id 978b128 lot# (b)(4) serial# implanted: (b)(6) 2020 product type lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 08-apr-2022, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 978b128 lot# va27nld implanted: (b)(6) 2020.Product type lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the caller was with the patient in the waiting room of the er.The patient went through the theft detector and felt like they were being electrocuted in the right buttock.The patient "dropped to the ground" and was shaking and "bawling" when it happened, they reported it was like a taser sensation.The caller reported that the leg was numb and the patient's "rear end and vagina hurt really bad." the area aroundthe device and "over the scar" was red and hot.The caller reported that this also happened a couple weeks ago at walmart, but the sensation eventually subsided that time.Troubleshooting was unable to be performed as caller had no equipment with them at the hospital.Patient services (ps) agent reviewed labeling for theft detectors; notifying field staff of situation.The caller did note that they were googling this situation and found other similar reports on the fda website.The patient didn't have falls or trauma.The caller indicated that the patient wants to sue or be compensated.Ps reviewed that at this time the focus is on reaching a local manufacturer representative (rep) to see if they can help.The caller also referred to the device as "malfunctioning" and "one of those devices that was recalled." the patient's current situation was described as "vibrating inside her" and that they were "hurting really bad." the same caller as before called back later in the day on (b)(6) 2022 with the patient restating the information previously recorded.The caller reported that for the last couple months, the patient had been getting electrocuted and that every time the patient would go to walmart or kroger's "or anything like that," the patient would get shocked and that today ((b)(6) 2022) was really, really bad when they went to through the metal detector at kroger.The caller stated that they sent a manufacturer representative (rep) out today and they also sent a note to the fda stating the device was malfunctioning and that the wires were broken inside of the patient and that's why it was electrocuting the patient.The caller stated they called a lawyer and told the lawyer what wasgoing on, told them that they knew of somebody else who was going through the same thing and that they were suing also.The caller said the lawyer's name is (b)(6) and that they took the case.The caller said the patient wanted to be compensated and that they were willing to do it out of court.Ps advised they could not talk any further about the issue now that the caller had a lawyer and placed the caller on a brief hold to consult on the issue; however, the caller then disconnected the call after a few seconds.Ps also wanted to note that as the caller was waiting for the patient's information to be pulled up, ps heard the patient scream "ow" in the background.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 15113776
• MDR Text Key: 304616267
• Report Number: 2182207-2022-01456
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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 Expiration Date: 09/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/27/2022
• Date Device Manufactured: 03/19/2020
• 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
• Treatment: "SEE H10...."
• Patient Age: 30 YR
• Patient Sex: Female