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

Model Number 97810

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Use of Device Problem (1670); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Insufficient Information (3190)

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

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: product id 978a128 lot# va27qua serial# implanted: explanted: other relevant device(s) are: product id: 978a128, serial/lot #: va27qua, ubd: 09-feb-2022, udi#: (b)(4) 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 representative regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor and urinary dysfunction/sacral nerve stim.The patient representative reported difficulty charging the implant and received code 2702.The patient said has always had difficulty recharging implant.The following troubleshooting steps were performed: located the implanted neurostimulator by looking for incision and/or palpating the area, caller said that they are unable to feel the neurostimulator which is a change which occurred about two years ago.When asked, patient confirmed significant weight gain or loss since implant.Other troubleshooting steps that were recommended that patient lean forward while sitting to optimize recharging position, apply gentle pressure to the recharging antenna.Reviewed meaning of code.The issue was not resolved through troubleshooting.An email was sent to the repair department to replace the device due to code however if this doesn't resolve patient was redirected to schedule an appointment to check neurostimulator site at hcp office.Additional information was received from the patient.The reason for call was the patient reported they were seeing a 'not found' message on their recharger application (new recharger) and that it had been happening for the last couple of days.Patient services walked the patient through resetting the recharging device.The recharging app initially showed the patient was connected to the handset but then the patient received another 'not found' recharger message.Patient services had the patient attempt another recharger reset and the patient then received a 2702 service code.The patient dismissed the code, and the recharger application then showed the recharger was "searching" and the patient was able to connect to charge their ins with excellent connection.The troubleshooting steps taken on the call resolved the reported issue but then the recharger lost connection from the ins and went back to searching.The patient stated they had been having a hard time finding the ins to charge it; that when they were at the managing health care provider (hcp) office a couple months ago, the hcp even had a hard time locating it.The patient stated that their caregiver had to help them charge and the patient had to lay on their side to connect to charge the ins.The patient stated the issue with difficulty charging the ins began a few months ago and that they had gained weight since they were implanted, and they thought the ins had shifted and was tilted.The patient stated they met with a manufacturer representative (rep) about the issue 2 weeks ago and the rep told the patient they might need to move the ins in a revision to resolve the issue.The patient then received a recharger inactive message on the recharger application and then the patient received a 1707 service code.Patient services reviewed the meaning of the service code with the patient.The patient stated that in addition to the difficulty charging the ins, the patient noticed that when their ins would get down to 40% -20% charge, they'd feel a weird sensation on their left side which their hcp had told them that's where the leads were.The patient couldn't stay connected to charge while on the call with patient services.The troubleshooting steps taken on the call did not resolve the reported issue.Patient services reviewed with the patient they could continue to work with their caregiver to get into an optimal position to attempt charging the ins however the patient would need to reach out to their hcp about the ins placement and difficulty charging.The patient stated they would reach out to their managing health care provider (hcp).

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.

Event Description

Additional information was received from the healthcare professional.It was reported that there was no device malfunction concern, but how the patient described their symptoms.The cause of the weird sensation was not determined, and has not resolved.

• 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: 17356086
• MDR Text Key: 319946422
• Report Number: 3004209178-2023-12944
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• Date Device Manufactured: 03/06/2020
• 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
• Treatment: "SEE H10...."
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 94 KG