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

Model Number 97800

Device Problems Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Pain (1994); Urinary Frequency (2275)

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that in december of 2022 they got their bladder stimulator replaced.They moved shortly after that and called their doctor, they could not refer them to another doctor.They told them to call the rep.Patient called the rep they said that their rep had moved up positions and there was a new rep and told them that they moved quite a long ways away so could not get a hold of the rep that's supposed to be their rep.They have called them several times, they don't have the option to leave a voicemail because it's always full.They have pain in their back, their stimulator was not working correctly.Patient had to turn it off for a doctor's appointment when they turned it back on they hit the down button on their stimulator and it says it's at full capacity and it can't go up but yet when they planted it in their back it was set at 1.5 and believe it's set at 1.2 now.  patient can't move it up and is going to the bathroom a lot more and can't get anybody to talk to them and help them find a doctor.There's one doctor in genesee county that will see them with a bladder stimulator and they refused to see them because they are not the doctor who implanted the bladder stimulator.And patient was not going to drive 3 hours away for a doctor's appointment.

Event Description

Additional information was received from the patient.They reported that their handset wont let the therapy go up.Patient is leaking and hasn't seen a doctor since implant.The issue was not caused by normal battery depletion.The issue was not resolved.The cause of the full capacity was not determined.The cause of being unable to adjust stimulation was not known.Patient requested we find them a doctor.

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: 19115839
• MDR Text Key: 340936874
• Report Number: 3004209178-2024-09146
• 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: 05/29/2024

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 Expiration Date: 02/14/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Date Device Manufactured: 08/23/2022
• 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 Sex: Female
• Patient Weight: 50 KG