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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

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

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 978b128 lot# va2eygc serial# implanted: (b)(6) 2021 product type lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 08-feb-2023, udi#: (b)(4) date of event: date is estimated; month and year are valid.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 (pt) with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and g astrointestinal/pelvic floor therapy.It was reported that the pt is trying to turn off their ins for an upcoming replacement surgery (see (b)(4)) and reported they are getting device not responding message.Following repositioning communicator on pt's ins, pt reported getting 'different internal device detected' message.Pt confirmed they still have the same implant.Pt continued getting device not responding and different internal device detected messages when trying to connect with their ins.Pt denied any recent trauma/falls to implant and stated implant still feels the same way it did when it was implanted.Pt stated their external equipment (handset and communicator) was left at a different house, so they had to go get it the other day and stated, over the weekend, they tried to connect with their implant once they got their equipment and that's when they were unable to connect with their implant.Pt stated it was "off for the longest time" however it was not clear as to what the pt was referring to by this.Pt stated they recharged both external devices but, since getting their equipment back, they have been unable to connect with their ins.Pt stated they have a pre-op appointment scheduled for january 19th.Agent did not ask about the circumstances that led to the reported issue.Agent did not collect external equipment serial number as pt was using equipment at call closure.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from a healthcare professional (hcp).The hcp reported that the cause of the device not responding message was determined and noted the likely cause as "leads not in place." the hcp indicated surgery will be on (b)(6) 2023, "on trospium." the issue was reported as being not yet resolved.

• 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: 16303403
• MDR Text Key: 308838346
• Report Number: 3004209178-2023-01626
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2023

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: 11/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/06/2023
• Date Device Manufactured: 06/03/2021
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 63 KG