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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927); Unauthorized Access to Computer System (3025)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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 (pt) who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that they stated "usually i receive a shock on mondays, i don't know why that is, i don't know if y'all do it from y'alls computer or something".Pt stated they figured this was from [manufacturer].Patient services reviewed that [manufacturer]/patient services cannot connect with pt's implant remotely.Agent tried to clarify if pt means they were getting a shock from their implant and pt stated "i believe".Agent asked for event date and pt stated the shocking had "been a while" and stated they memory loss.  agent asked if when pt noticed shocks if they were near any emi.Pt stated they had thrown out their microwave and anytime they go through a walmart, they were told that "those kind of devices, turn this off" so pt stated they had been ordering online.Pt made comment on the call that they can "feel it now" (agent unclear what pt was referri ng to by this comment).Patient was redirected to their healthcare provider to address the issues.

Manufacturer Narrative

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

Additional information was received from a manufacturer representative (rep).The rep reported that the rep's suggestion to the patient and their physician was to remove the device.The patient does not want to do this.There is nothing further the rep can do.

Manufacturer Narrative

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

Additional information was received from the patient.They called back regarding previously noted issues.Patient stated they fell 5 days ago on their back and have a big bruise on their butt.Patient stated their back really hurts, patient was redirected to hcp.Patient again stated they were not feeling the "shock" they normally feel as previously noted.Patient again inquired about ins battery status.Patient was able to connect to ins and stated that therapy was off.Patient turned therapy back on, but said it kept going off on its own.Patient changed to a different program and increased stimulation until they could feel it and it was comfortable.Walked patient through checking ins battery and patient confirmed it said "ok".Patient directed to hcp regarding battery level.Patient again mentioned they threw their microwave away because it was shocking them.Patient was difficult to follow and was clicking on things on the handset without direction from agent.Patient was redirected to hcp regarding their pain and symptoms.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 18021373
• MDR Text Key: 327314903
• Report Number: 3004209178-2023-18515
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

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: 08/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 10/27/2023; 01/24/2024
• Supplement Dates FDA Received: 11/20/2023; 02/09/2024
• Date Device Manufactured: 02/16/2019
• 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 Sex: Female