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

Model Number 3058

Device Problems Break (1069); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994); Shaking/Tremors (2515); Device Embedded In Tissue or Plaque (3165); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3058 lot# serial# (b)(4) implanted: (b)(6) 2020 explanted: (b)(6) 2021 product type implantable neurostimulator product id 3889-28 lot# (b)(4) serial# implanted: (b)(6) 2020 explanted: (b)(6) 2021.Product type lead product id 3889-28 lot# (b)(4) serial# implanted: (b)(6) 2020 explanted: (b)(6) 2021.Product type lead.Other relevant device(s) are: product id: 3058, serial/lot #: (b)(4), ubd: 14-jul-2021, udi#: (b)(4); product id: 3889-28, serial/lot #: (b)(4), ubd: 30-jan-2024, udi#: (b)(4); product id: 3889-28, serial/lot #: (b)(4), ubd: 30-jan-2024, udi#: (b)(4), date of event.Date is estimated; year is 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 who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient wanted to know if they were able to get an mri.Patient stated they had both ins devices and the leads explanted on (b)(6) 2021.Patient is told that "there are two devices in me that are abandoned." patient stated they were not able to get an mri due to abandoned product.Patient said the reason they had the devices removed is because they had problems with both devices.Patient said "instead of going to my intestines it was going to my legs and causing shaking as well as other issues." patient stated that they followed up with hcp by (b)(6) 2020 that there were issues and said it wasn't working.Patient stated "they did nothing and tried to reset and it still wasn't working." patient said in november they told hcp that "there is something wrong it was irritating my back." patient stated they wanted stimulators taken out.Patient said in (b)(6) (2021), the stimulators haven't been on in almost 3 months and was experiencing sharp pains down the leg.Patient said "it's pushing on something it's not supposed to." patient said on (b)(6) 2021 the explant surgery was supposed to be an hour and it was 3 hours and "everyone (doctors) was there".Patient said "it was stuck in my spine and that's why it was taken out." patient asked if "piece that is stuck; a little mini piece" could be abandoned product.Patient reported they have a lead that fractured (patient did not clarify which lead this is related to).Patient says the hospital system has no record of the devices and leads being removed.Agent redirected to hcp to confirm if entire system was explanted and patient stated "i have x-rays that prove it was." due to the nature of the call, agent made best attempt to gather all relevant information.The patient was redirected to their healthcare provider to further address the issue.The patient mentioned unrelated medical history.This included patient also has a pacemaker and said that device and lead is mri safe.Patient mentioned they need head/brain mri scan for possible ms diagnosis.

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.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

Additional information was received from the patient.They reported that they had leakage and urinary stimulator being removed.Reiterated with any piece of lead not removed.

• 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: 15511181
• MDR Text Key: 300884786
• Report Number: 3004209178-2022-12626
• 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: 10/20/2022

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: 07/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/20/2022
• Date Device Manufactured: 01/22/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female