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

Model Number 97810

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

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 fecal incontinence and gastr ointestinal/ pelvic floor.It was reported that yesterday and all today the battery would flash up and down on the recharger like it was not charged and would not turn on or off. the patient unplugged it left it off all night and tried again today.Now it is charging but having problems connecting to the handset.The patient also reported that sometimes the recharger finds the ins quickly and sometimes they have a lot of difficulty finding an optimal position to sustain an ins charge session.The patient also felt a little shocking sensation when using the recharger.The shocking occurred when the charger as over bare skin an the belt was not used.It was felt where the recharger was touching the skin over the fully healed incision.The sensation only occurred at the beginning when the patient was still trying to find the best position for the recharger.It occurred consistently for every charge session.The patient was seeing a recharger not found message.The patient reported a 1707/coupling issues error.The following troubleshooting steps were performed; reset the recharger, dismissed code, located the ins by looking for incision and/or palpating the ins, repositioned the recharger, moved the charger away from the lead, recommended patient lean forward while sitting to optimize ins position, recommended using recharger over a thin layer of clothing, the recharger not found message was resolved after resetting the recharger; however, the patient continued to have difficulty maintaining charge session. the patient had always had difficulty recharging the ins.They are somewhat overweight but the ins feels flat under the skin.The patient normally lays down while charging and has their spouse lay a book on top of the recharger in order to apply steady pressure. it was unknown whether the shocking was resolved as the patient was going to try again when they were home and their husband could assist them. the patient will continue trying to charge when they get home with the assistance of their spouse.Patient services recommended patient follow up with managing physician if recharging difficulties persist.Additional information received from a manufacturer representative (rep) started that the difficulty maintaining connection to recharge was most likely due to depth.Nurse said implant might be 1-1.5 inches deep.Nurse stated sensitivity was from the healing incision.The patient is to follow up with nurse practitioner.The belt was used and resolved the sensation issue.No layer of clothe was use.The patient was not yet able to successfully recharge the implant.

• 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: 18884921
• MDR Text Key: 337417703
• Report Number: 3004209178-2024-06857
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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 Expiration Date: 04/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Date Device Manufactured: 11/04/2020
• 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 Age: 44 YR
• Patient Sex: Female