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

Model Number 97810

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Distress (2329); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978a128 (lot: va2bq9q); product type: 0200-lead; implant date (b)(6) 2021.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.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 gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that the patient said they have not used their stimulator in over a year because it did not solve their problem, they repositioned the wiring but it never helped.Agent worked with patient to use the charger and after restarting the handset, turning off wi-fi and restarting the charger by holding down the power button for 45 seconds, patient was successful to start a charging session with excellent connection.The ins progressed to 10 percent and therapy was off.Shortly afterwards, patient reported seeing the ins battery level por message, dismissed it and continued charging.Reviewed the meaning of por and recommended charging to 100 percent.The troubleshooting steps that were taken on the call resolved the issue.The patient's relevant medical history included that, during the call, patient also reported they want to have the device removed because it never helped them at all, and it is causing so many problems.Pt said they did not do an evaluation prior to getting the permanent ins.Offered and sent email with mri information.Pt also expressed frustration with the external equipment because it charges so slowly.

• Brand Name: INTERSTIM
• 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: 18646708
• MDR Text Key: 334610420
• Report Number: 3004209178-2024-03647
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• 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: 02/05/2024

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: 05/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Date Device Manufactured: 11/25/2020
• 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: 72 YR
• Patient Sex: Female