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

Model Number 3058

Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Unstable (1667); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was patient said after they got their stimulator it helped their symptoms, but it hasn't worked in a couple of years.They don't know the date, it's been a while, their stimulator stopped working.They started complaining about it not working and they brought in someone to check it and realized it wasn't working, and they were supposed to come and do some other tests but never did get a time, date and never got around to doing it.Pt also said they think it shifted and they noticed it started burning inside.The urologist they have been seeing, felt it and said it was flipped and tried to use their handset and communicator but they did not work to connect to it.Pt said, they asked them to remove it but nothing has been done and now they have moved and no longer see dr.(b)(6).Pt said they had no falls or accidents.The patient was redirected to their healthcare provider to further address the issue.Note call disconnected, called pt back to ask if they knew rep name and date.They met with the rep 3 call recordings.Patient's hcp said the lead location doesn't look like what she is used to seeing.Unknown if lead has migrated.Hcp reports the "programmer does not connect.".

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.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 978b128 lot# va294nd serial# implanted: explanted: product type lead 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 unknown indications for use.The reason for call was patient said after they got their stimulator it helped their symptoms, but it hasn't worked in a couple of years, they don't know the date, it's been a while, their stimulator stopped working, they started complaining about it not working and they brought in someone to check it and realized it wasn't working and they were supposed to come and do some other tests but never did get a time and date never got around to doing it.Pt also said they think it shifted and they noticed it started burning inside, the urologist they have been seeing, felt it and said it was flipped and tried to use their handset and communicator but they did not work to connect to it.Pt said, they asked them to remove it but nothing has been done and now they have moved and no longer see hcp.Pt said they had no falls or accidents.The patient was redirected to their healthcare provider to further address the issue.Patient's hcp said the lead location doesn't look like what she is used to seeing.Unknown if lead has migrated.Hcp reports the "programmer does not connect.".

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 16657593
• MDR Text Key: 312970950
• Report Number: 3004209178-2023-04357
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2023
• Date Device Manufactured: 02/14/2020
• 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...."