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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)

Patient Problems Seroma (2069); Electric Shock (2554); Insufficient Information (4580)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 3889-33 lot# (b)(4) serial# implanted: (b)(6) 2019 product type lead.Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 04-dec-2022, 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 fecal incontinence and gastr ointestinal/ pelvic floor.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported their communicator is trying to search for their ins but it "never finds it".Walked pt through connecting with pt's ins and pt confirmed they were able to successfully connect with their ins.Pt stated "this is the first time it worked in ages." pt stated when it wasn't working there was a circle that just kept going around.Pt stated this occurred two days ago when they tried to increase stimulation.Pt then reported the biggest problem is that with their previous handset pt had stimulation at "like.9 or 1" but stated with the new handset pt has stimulation up to 1.4 but pt is not feeling anything.Pt clarified that with new handset, pt has stimulation higher.Pt stated on the call they did not feel any stimulation.Pt stated when they first increased stimulation to 1.4 pt "felt a little buzz" like they use to, but then stated it went away.Agent tired to clarify if pt is getting a 50% reduction in symptoms and pt stated they are "getting oozing and tiny amounts of stool".Pt then clarified therapy is not managing their symptoms by 50%.Reviewed external equipment/therapy.Pt stated they had back surgery and stated they had a double laminectomy on the last 3 lumbars and stated they took the facets out and did a partial discectomy and also did bone spurs.Pt stated after the surgery on may 31st pt first started feeling symptoms (that therapy is not helping by 50%).Pt stated prior to this therapy was perfect and pt was getting 95%.Pt stated it was working perfect but the "wires started to shock me".Pt stated they have already gone to the hcp.Pt stated they thought maybe if they turned therapy off for a couple hours and back on not so high that might help.Recommended pt decrease stimulation/turn off ins and follow-up with hcp.Agent asked for event date of shocking event if this has been since surgery on may 31st and pt stated "probably about 2-3 weeks later when i ended up with a seroma".Pt stated this was a fluid filled sac that was underneath pt's incision where they had their back surgery (pt stated this is on top of their s2).Pt stated their lead is going to their s2.Pt stated their ins was turned off for surgery.Pt was using communicator at call closure so agent was unable to collect communicator sn.Agent did not ask about the circumstances that led to the reported issue.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• 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: 15537888
• MDR Text Key: 306641425
• Report Number: 3004209178-2022-12836
• 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: 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: 10/04/2022

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/04/2022
• Date Device Manufactured: 10/15/2018
• 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: 71 YR
• Patient Sex: Female