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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 12/25/2023

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 when they got their stimulator they did not have any low back pain when the doctor put it in and it healed up.Pt said they went to the chiropractor in (b)(6) because their low back was out and they adjusted it.  pt said since they saw a chiropractor between christmas and new years, around the (b)(6), now they were not sure if their stimulator was working.Pt said when they saw the chiropractor, the chiropractor used a vibrator on the lower part of their back and now they think that messed their device up and it has been messed up since that time. pt said they may have told the chiropractor they had a stimulator but didn't remember if they told the chiropractor before or after the adjustment and vibrator use.The patient requested assistance to use their equipment to turn therapy off.Patient said they had never called and never used their equipment.They had not been back to the doctor because they were embarrassed but now when they stood up to walk, their low back on the left side, where the ins is located, hurts with a dull pain.Pt also said that where the stimulator is, it used to be flat and now it was like a point in the middle of the scar.Their daughter took a picture of it.They thought it may have moved.Patient services worked with patient to use the equipment to try to turn therapy off and after several tries to reposition and restarting the handset/ toggling wifi off, bluetooth and location off and back on, repositioning several more tries, patient was successful to synch with their ins and turn therapy off. pt said they saw another chiropractor recently because their low back was out and the recent chiropractor adjusted it and now their low back is not out.Patient services redirected to report their issues to their managing doctor.

Manufacturer Narrative

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.

• 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: 18869374
• MDR Text Key: 337623864
• Report Number: 3004209178-2024-06655
• 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: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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
• Date Manufacturer Received: 03/06/2024
• Date Device Manufactured: 04/25/2023
• 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: 78 YR
• Patient Sex: Female