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

Model Number 3058

Device Problem Difficult to Remove (1528)

Patient Problems Bacterial Infection (1735); Device Embedded In Tissue or Plaque (3165)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name interstim; product id 3889-28 (lot: va1837u); product type: 0200-lead; implant date (b)(6) 2016.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 gastrointestinal/pelvic floor, urinary dysfunction/sacral nerve stim.It was reported that patient had the stimulator removed (b)(6) 2021 (she isn't sure on the day).The doctor couldn't get the leads out.The patient still has the lead in her.She needs to have an mri on her neck.She was having a lot of issues with her neck and she thought she had it in there for 5 years.Patient had it removed for an mri.She went to have the mri and she freaked out.She has claustrophobia.She opened her eyes and it was like her nose was almost touching the screen.She freaked out and they told her she had to have a 1.5 machine.They put the i.V.In her but it was going to put her to sleep.She goes back in the room and the doctor was coming in to put me to sleep and they said no you can't be put to sleep because if something happens to the leads in the sacral area you need to be able to tell us.Patient was in the hospital for 12 days and almost died because she got a staff infection.Now she needs an mri of her lower back and hip area on the left side.She knows the implant is on the right side.Patient said, the doctor that did the removal couldn't remove the lead and left the whole lead behind.Patient got a staph infection from it.She said, i forgot what the heck it's called mrsa or something like that.The issue was not resolved through troubleshooting.The caller was redirected to their healthcare provider to further address the issue.Explained there is new guidelines for abandon leads that the doctor would have to determine her eligibility.

• 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: 18747409
• MDR Text Key: 335872350
• Report Number: 3004209178-2024-05335
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 02/21/2024

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: 12/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/21/2024
• Date Device Manufactured: 07/01/2016
• 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): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female