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

Model Number 3058

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Scar Tissue (2060); Seroma (2069); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient's ins has already been removed but the lead remains implanted.Currently the patient's (pt) lead is showing as explanted but the pt stated it is still implanted.This was confirmed with ct scan and an mri.The pt is trying to get the lead removed because it's been causing pt pain.The pain pt is experiencing was described as "slicing or a scratching sensation every now and then" because it's currently "floating in pt's body" and moving at random times.The "clip" on the lead is causing pt pain.Pt reported they are a "disaster". per pt, they were initially informed by the hcp that the ins and lead were removed together.However, during their pain pump explant on (b)(6) 2023, the hcp found out that it is still implanted.It was found behind/under a pocket of fluid under/behind the pain pump catheter.The pt stated that was part of the problem as it was not seen until recently. it is 3 inches under the skin and already encased in scar tissue.Pt suspects its location is why it was not found in their tests prior to removal of the pain pump.Pt still in the process of looking for a doctor to have it removed. pt reported they were in the hospital and have been in the hospital off and on since (b)(6) 2023.Pt stated they had a hernia repair in the process and got over that.The pt stated around (b)(6) 2023 when the other device (pump) was explanted they started having issues and they were put in the hospital.Pt stated they had problems off and on but they thought it was due to other pain issues like their sciatica.Pt stated when they got sick again because there was a pocket of fluid, which the pat confirmed to not be "infectious." pt stated they do not know the exact date but stated it was around the (b)(6) 2023 "so like the first couple of days of (b)(6) 2023".Pt stated "nobody will touch it, that's the problem".Pt stated their reason for call was to notify us that their lead is still implanted as "you guys have it on record that it was taken out".   agent did not ask about the circumstances that led to the reported issue.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va29r3l); product type: 0200-lead; implant date (b)(6) 2020.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.

• 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: 17698036
• MDR Text Key: 322820264
• Report Number: 3004209178-2023-15485
• 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
• Report Date: 09/07/2023

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: 03/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/07/2023
• Date Device Manufactured: 09/15/2020
• 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...
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female