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

Model Number 97800

Device Problem Energy Output Problem (1431)

Patient Problems Headache (1880); Device Overstimulation of Tissue (1991); Pain (1994); Urinary Retention (2119); Ambulation Difficulties (2544)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction, urge incontinence.It was reported that ever since they got the implant they've had trouble connecting to the stimulator and now it seems like it is getting worse, the rep had trouble at implant too.Patient said every other time they use it they spend 40 minutes trying to get it to connect and it keeps saying can't find device, retry.Worked with patient to power down the communicator, turn wifi off, bluetooth off and back on, location off and back on and airplaine mode on and back off, restart the handset then try to connect to the implanted neurostimulator and patient was successful to connect.Worked with pt to remove the communicator, power the communicator down, end the session, power the communicator up again and try again and pt reported seeing device not responding, tried again several times and continued seeing: device not responding.Patient repositioned the blue and white communicator several times and reported seeing the same message.Patient reported they can feel the stimulator under their skin and eventually they can find it but it is taking a long time, it shouldn't and the pain gives them headaches.The issue was not resolved through troubleshooting.An email was sent to the repair department to replace the device.During the call pt said when they are at work they dont have the time to spend 30 minutes on their break to do mytherapy and can't get it stuck too high up or they can't walk.Called pt back to clarify this statement.Pt said they have to increase and then eventually it will do it's job, they will know and they will have to use the restroom then after they use the restroom, but once they can go it becomes way too strong and they can feel it right away.Pt said they don't know why, but then they have to hurry up and decrease, it's beneficial to decrease before they go, if they can decrease before they use the restroom that is their best shot.Pss asked pt if they have urinary retention? pt said their bladder will not empty out everything and sometimes they don't go and they may drink a bunch of liquids so they look like they are 20 pounds heavier.And/ or, it helps them go number 2.Pt said this is how they have used interstim and this is how they used their previous stimulator.They don't' decrease and increase every day but while they have their period they increase more because they are in more pain and need more help with their symptoms.Did not ask for more clarification because pt provided so much confusing information.

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 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: 18307607
• MDR Text Key: 330226187
• Report Number: 3004209178-2023-25549
• 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
• Report Date: 12/11/2023

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: 12/08/2023
• Initial Date FDA Received: 12/11/2023
• Date Device Manufactured: 04/14/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female