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

Model Number 97800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Micturition Urgency (1871); Headache (1880); Burning Sensation (2146); Electric Shock (2554); Insufficient Information (4580)

Event Date 07/17/2023

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence and urinary/bowel dysfunction.It was reported that the patient has experienced a burning sensation at the rectum and a little shocking sensation on the right butt cheek when they sit up straight.The patient states this started the day they got home from the trial.Patient service specialist asked if the patient has made any adjustments and the patient stated no.The patient reports that they have urgency and hasn't yet noticed any improvement in bladder symptoms.Reviewed therapy information and general programming guidance.With instruction patient connected to their neurostimulator and decreased the setting until the burning sensation stopped.The patient will maintain stimulation level and will continue to track symptoms.Confirmed stimulation in bicycle seat area and comfortable.They also reported that since the date of implant they have experienced a headache and the patient took a tylenol and for now the headache has subsided.The patient said they typically don¿t get headaches.The patient was redirected to their healthcare provider to further address the 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

Information was received from a patient with an implanted neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.They reported that they can tell a difference in their bowels, but reported most days their bladder is "not good".Reviewed indications for use and redirected pt to healthcare provider to discuss therapy/symptoms.When agent asked for event date for when pt noticed they have not been getting good improvement with bladder pt stated "it hasn't been great since i had it done".Pt reported some days are worse than others.Pt repeated that they are having a lot of burning in their rectum/bottom.Patient stated that they tried decreasing stimulation yesterday from 1.2 to 1.0, but that really didn't make a difference.Patient said that if they sit for any length of time, even though they move from side to side "or whatever", the longer the day goes, the more it burns.Patient mentioned that they have lichen sclerosus (an autoimmune disorder) that pt stated "they were aware of this".Pt stated this is a rash they get that they also have on their bottom.Pt stated they don't know if that's irritating it or what's going on.Pt stated before they had implant if they would use their steroid cream "in the front" it would solve it, but stated it's not right now.Reviewed role of pt services and redirected pt to healthcare provider to address this issue.Reviewed option to continue decreasing stimulation or turn off therapy to see if that helps and follow up with healthcare provider.Pt mentioned that they were experiencing "little electrical shocks" as previously reported and stated the shocking went away but the same burning sensation has continued.Pt mentioned the surgical site is fine.Pt was redirected to healthcare provider to address the issue.

• Brand Name: INTERSTIM X
• 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: 17372243
• MDR Text Key: 320152709
• Report Number: 3004209178-2023-13084
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: 08/28/2023

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/28/2023
• Date Device Manufactured: 04/21/2023
• 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 Age: 72 YR
• Patient Sex: Female