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

Model Number 97810

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they had an mri done about 3 weeks ago and since then they feel like their implant area has been very hot.Pt reported since mri scan they feel like something is wrong with it (pt's ins).Pt stated when they left the "guy" told pt to watch if pt notices anything different.Pt stated it was hot that day of the mri scan and pt was driving a lot so pt thought they were just hot from that but then when they were sleeping they felt the heat again.Pt stated they turned off their ins because when they tried to charge their ins it shocked pt.Pt stated when they were trying to charge their ins it would not connect and stated they have been having problems with getting it to "connect and sync" with their ins since the mri scan.Pt reported following mri scan they were trying to charge their ins and suddenly felt like someone tazed pt.Pt confirmed ins was put into mri mode for the mri scan.When agent asked for event date pt stated they have "been having little sensations of shocks", but reported since mri scan shock hurt so bad that pt fell to the ground.Pt stated due to this they turned off their ins and their ins is currently off.Pt confirmed not feeling shocking since ins has been turned off but reported feel "a pinching".Recommended pt keep ins off and follow up with hcp to check ins/further discuss issue.Pt stated hcp has left the practice.Pt stated they will contact hcp office to see who may assume pt's care.Emailed pt hcp listing per pt's request.Redirected pt to hcp to further address this issue.

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 and patient stated that the shocking was not only felt during recharging and that they were wearing a layer of clothing when charging.The issue was not resolved.

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.The patient reported that they'd had a problem early on (in april) this year when they went to get an mri scan.The patient stated the techs usually would do their mri mode for them but this last time, the tech told the patient that they would have to put themselves in mri mode and the patient told the tech they didn't feel comfortable doing so but they attempted to do it.The patient stated they weren't sure if they did it correctly, but the ins got hot "like water" after they had the scan.The patient stated that the ins was causing more pain than it helped and that they would get shocked, so they've had it off.The patient stated it felt like they were getting tased.The patient stated they could be sitting, standing no matter what they were doing, charging or not, off or on, they could get an electrical shock and that they were afraid to have the ins on because it was getting worse when it was on.The patient stated the shocking didn't' start from the mri, however that it had started happening probably within a month of them getting implanted.The patient stated since the device/therapy was their last resort, they initially thought maybe they should "just get used to it" but the shocking pain had never let up.Patient services wanted to note the patient was difficult to follow at certain times and patient services did their best to record the reported information.The patient mentioned that "it" was "dead" even when they had it on the charger.Patient services tried to clarify if they were talking about the recharger, but the patient never fully clarified their comment and just stated the ins would "literally" shock them when they were trying to connect to their ins, and that the shocking always came from the ins.Patient services redirected the patient to follow up with their managing health care provider (hcp) to check the implanted system.The patient stated they would no longer have an hcp as of (b)(6) 2023 and requested physician listings.Patient services sent the patient hcp listings.Documented reported event.No further action was taken by patient services.

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.

• Brand Name: INTERSTIM
• 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: 17101950
• MDR Text Key: 316935387
• Report Number: 3004209178-2023-10181
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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,Followup
• Report Date: 09/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/10/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 08/22/2023
• Supplement Dates FDA Received: 07/25/2023; 09/14/2023
• Date Device Manufactured: 09/29/2021
• 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
• Patient Weight: 73 KG