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

Model Number 3058

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 and gastrointestinal/ pelvic floor.It was reported that starting around the 13th of january they just woke up and noticed "pain in their bottom" it has been bothering them for the last couple of weeks.Pt said they feel it more around the implant area, they have tried turning stim down and off and did not notice any improvement.Pt said it hurts to bend or sit and then stand up but they have not had any falls or traumas.Pt said they sent an online message to their doctor and were directed to call patient services.Reviewed if they have tried changing programs, turned stim down or off and the issue did not resolve it would be best to continue seeking help from their doctor.No device issues were reported.On sep-27-2022, additional information was received from the patient.They reported that the patient and the doctor had been noticing that the patient was having trouble walking in the last couple weeks.They are trying to determine if it is related to the medication or the stimulator.The doctor doesn't think it is related to the medicine.Patient thinks it is related to the implant causing pain.When patient saw the doctor in (b)(6) they said the device was good for another 22 months.In august they were told the stimulator battery was dead, so it didn't last five years like it was supposed to.Their doctor is out for a while because they are having surgery.Their physician assistant said their stimulator battery was critically low and would be dead by october or november.Patient is scheduled to have they think, just the stimulator replaced the middle of november by a different while their doctor is out.Their pain location is around the implant site down to the feet.Had the patient synch the patient programmer with the stimulator.Patient showed stimulation was on 4.1 volts and it did not show a low battery icon.Suggested lowering stimulation, however the patient said they have never been able to feel the stimulation vibrate since implant and he did not want to try lowering stimulation to see if the pain in the leg would go away.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.On oct-06-2022 e1, e2 no new information.On oct-18-2022 lfc (hcp): no new information.

• Brand Name: INTERSTIM II
• 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: 18869622
• MDR Text Key: 337260369
• Report Number: 3004209178-2024-06660
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: 03/08/2024

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: 12/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 03/08/2024
• Date Device Manufactured: 06/14/2018
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male