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

Model Number 97800

Device Problems Pocket Stimulation (1463); Insufficient Information (3190)

Patient Problems Incontinence (1928); Itching Sensation (1943); Discomfort (2330); Dysuria (2684)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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.It was reported that their device is not working.They get up and it pours out of them again.Patient stated they think they may have been turning therapy off previously.Patient said they had just increased stimulation and were feeling it where their ins was.Patient service specialist reviewed general theory and use of external devices.Patient was able to successfully connect to implant and decrease stimulation to a comfortable level.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.

Event Description

Additional information was received from the patient.They reported that they were sore in their vagina and butt and it was itchy.Patient wanted to walk through how to use external equipment.Walked patient through connecting to ins, patient had stimulation at 0.1.Patient decided to increase stimulation to a comfortable level.Patient stated they felt stimulation in between their legs instead of ins location as previously noted.Patient stated it also hurts to go to the bathroom.Therapy adjustment options reviewed.Patient was directed to follow up with hcp regarding symptoms.Patient stated they have an appointment with hcp on (b)(6).

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 repeated previously reported therapy issues.Patient said device is not working and has tried all seven of the programs.Patient said maybe helped a little for a short period of time however is back to wearing depends at night and when stands, urine just pours right out and has no control.Patient said that the trial was wonderful.When asked patient stated hasn't had any falls, trauma, or heavy lifting.Patient said that sometimes has increased the setting to the point of discomfort hoping then will experience some improvement in symptom control.During call patient did decrease setting so that stimulation sensation is comfortable.Patient also mentioned that at times only feels stimulation at ins site.Patient said they have discussed results with their healthcare provider (hcp) and was told to continue trying the different programs and redirected to call medtronic.Patient said their hcp mentioned adding medication however patient said they don't want to be on medication.Patient said was on medication before implant but didn't take any medication during the trial and afterwards.Reviewed therapy information and general programming guidance.When asked, patient hasn't been tracking adjustments.Patient will start working one program at a time, noting setting, where feels stimulation sensation and results.Patient was redirected to schedule appointment with hcp if they don't notice at least 50% improvement on any of the standard programs, to request diagnostic testing be performed and also adding custom programs.

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 X
• 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: 18290023
• MDR Text Key: 330001938
• Report Number: 3004209178-2023-25399
• Device Sequence Number: 1
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 01/25/2024; 04/11/2024
• Supplement Dates FDA Received: 02/09/2024; 05/01/2024
• Date Device Manufactured: 08/11/2023
• 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: 68 YR
• Patient Sex: Female