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

Model Number 97800

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Diarrhea (1811); Unspecified Infection (1930); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Vomiting (2144); Burning Sensation (2146); Twitching (2172); Electric Shock (2554); Insufficient Information (4580)

Event Date 12/14/2023

Event Type  Injury  

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 urinary/bowel dysfunction and urge incontinence.It was reported that ever since they got the implant, they'd had little jolts of pain here and there which wasn't totally uncomfortable, but it was alarming.The patient stated that over the past 4 days, however, it had been multiple times a day that the jolting set them on fire/was "stead fire" and that it went down their butt, their thigh and down their leg towards their foot and that their foot would twitch.The patient stated when they touched the skin over the implant itself, it felt kind of warm to the touch.Patient stated they've tried increasing and decreasing the stimulation but that hasn't helped at all.Patient services reviewed with the patient to turn the ins off until they could follow up with their health care provider (hcp), reviewed the possibility of infection given the warmth at the ins site and redirected the patient to seek medical care and follow up with their health care provider (hcp).The patient stated that they had thought they just had a stomach bug up until now, but also 4 days ago when the shocking started, they went to the er because they were having really bad diarrhea and throwing up and that they had bloodwork done and the bloodwork showed their white blood cell count was 16 and that anything over 10 would set off the alarm for an infection.The patient stated they never correlated the shocking with the infection and the ins until now but they were wondering now if the infection was related to the shocking at the ins site.The patient stated they called their health care provider (hcp) already and the hcp told them to call medtronic.Patient services reviewed the role of patient services and the rep with the patient and stressed the urgency of seeking medical attention for their issue but sent an email to the field to alert them of the situation.The patient stated they were going to call their hcp back after they hung up with patient services and noted that they still felt nauseated at the time of the call.Documented the reported event.No further action was taken by patient services.

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.

Event Description

Additional information was received from a healthcare professional (hcp).No clarification on cause/likely cause was noted.The hcp reported that the steps taken were that patient was seen in office and the program was changed on 2024-mar-07.The issues were reported as being resolved.

• 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: 18883649
• MDR Text Key: 337404306
• Report Number: 3004209178-2024-06839
• 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
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 10/13/2023
• 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 Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 141 KG