MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Electric Shock (2554)

Event Date 02/28/2020

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary retention.It was reported that manufacturer representative (rep) was contacted by a patient who experienced a painful sensation, sudden and strong surge in stimulation as they exited a shop.It was felt in their vaginal area and caused them to double over in pain.It hasn¿t happened since but has caused a lot of concern for the patient if it were to happen again. they had a n unrelated procedure back in november 2023, and have been aware of intermittent increases in stimulation coming and going, but nothing to cause the pain and discomfort as yesterday.Rep has advised that they switch off their device if they are going into shops for the time being.Additional information was received.It was reported that this was the first time patient felt this when passing theft detector ports.The cause was unknown but that issue was related to the electromagnetic interference from the store/stop.They were not aware of any other factors.Patient being reviewed/seen in clinic on 2024-mar-22.

Manufacturer Narrative

G2: country united kingdom 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

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the steps that be will be taken are that the hcp will discuss with the patient a battery revision as there is likely fluid in the header.The issue has not yet been resolved.

Event Description

Additional information was received.The manufacturer representative (rep) reported that patient did not experience this before implant.Patient had only felt this when passing through the theft detectors.Following surgery, patient has been experiencing some weird /stronger surges of stimulation, similar to what they would get when having an impedance check.Happened a few times, but none as strong as the one they experienced leaving the shop.No signs of swelling or redness.Patient did switch it off for 2 weeks and no shocks experienced since then but the symptoms have returned.During clinic visit (b)(6) 2024, rep checked impedances and they were all within range.The healthcare professional (hcp) palpated the device when it was on and also switched off.When on at 0.5 (patient's normal level of stimulation) on palpating on top of the ins and to the side where the wire comes out of the header, hcp was able to recreate the shocking sensation patient has experienced.When reduced to a lower amplitude (0.1/0.2) patient still experienced them but not as strong.When the device was switched off, there was no shocking sensation on palpation in the same area.The patient is going to leave the ins on at 0.1 to 0.2 and see whether that is sufficient to control symptoms without it being uncomfortable.Xrays were done.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received.The rep reported that the patient is due to have surgery in late june, following discussion with the hcp.The plan is to probably change the battery, though will assess once in theatre.No date has been confirmed yet.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18894125
• MDR Text Key: 337552500
• Report Number: 3004209178-2024-06979
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2024

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: 06/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 04/08/2024; 05/02/2024
• Supplement Dates FDA Received: 04/01/2024; 04/15/2024; 05/08/2024
• Date Device Manufactured: 12/21/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female