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

Model Number 97810

Device Problems Unintended Collision (1429); Energy Output Problem (1431); No Device Output (1435); Charging Problem (2892); Insufficient Information (3190)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

Information was received from a patient regarding an implantable neurostimulator for the treatment of bowel issues.It was reported that  the device stopped working quite a while ago.Patient said they went back to the doctor and they said they have never seen this before and they don't know why it didn't work.Patient called back and said they want to have it fixed or replaced but the doctor never called them back.When asked what stopped working, patient said it wouldn't charge or would charge but wouldn't stimulate or would not  turn on.Patient tried all the programs and went into the doctor's office and went through all that and nothing worked, it was stuck on some low strength and wouldn't increase.Patient also said the doctor said it had something to do with grounding but patient didn't know what grounding meant.Patient didn't get the medtronic representative involved at all because the representative had just left.The patient was redirected to their healthcare provider to further address the issue.Agent did not ask about the circumstances that led to the reported issue.Patient was in a car accident after the device stopped working and they did an x ray of the spine they saw the device.Patient said the device stopped working towards (b)(6) 2022.Patient is needing to have a mri.Patient's ins is not charged.Patient will charge ins and external devices and call back for assistance activating mri mode.

Manufacturer Narrative

B3: date is approximate.Year is confirmed 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.

• 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: 17905593
• MDR Text Key: 326251353
• Report Number: 3004209178-2023-17333
• 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: P080025
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/10/2023
• Date Device Manufactured: 09/28/2021
• 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 Age: 59 YR
• Patient Sex: Female