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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949)

Patient Problems Incontinence (1928); Urinary Retention (2119); Ambulation Difficulties (2544); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

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 gastrointestinal/ pelvic floor.It was reported that the patient said it has been a while now that it doesn't work at all at night, and during the day she is having bladder spasms.It stated in early june and by august it was really bad.When she has the bladder spasms some times she can't move or get off the couch.Once the spasm unclenched she can move and get to the toilet, but then can't pee some times have to sit there 10 minutes.She doesn't void completely.She wiggles her hips and legs like her doctor told her.She brushes her teeth and hangs out in the bathroom.Just above the pubic bone she can tell there is something in there.Then it will release.Sometimes it takes 3-4 voids before she is completely voided.The stimulator on the left side she noticed last week looks like an indentation below it, looks like it is right at the surface.The stimulator just seems the top partis moved and bottom is pushing down.She said, the doctor said it was really difficult putting in because lot more scarring then they had seen on fluoroscopy screen.They did the best they could.Patient was doing fairly well.February she went in for follow up.She took both remotes into appointment.The gal saw her and at the time the patient was doing pretty well making it through the night.At the appointments they usually go in to double check the stimulator.She assessed it and within a week or two started a slow drip at night.Sometimes the patient is up at 2 or 3 am because she has gone through the adult briefs and through even into the pads she sleep on underneath her.Patient is careful what she drinks two hours before bed.Patient mentioned she was getting zapped down the leg.Patient said it seems her autonomic nervous system is shutting down.The patient spoke to doctor's assistant and she hasn't heard back from her.Agent did not ask about the circumstances that led to the reported issue.Patient wanted to know what the difference in the programs were and which one she should go to.Currently she is on program 6 at 3.5.This last time she tried to move from 3.5 to 3.7 the buzzing was too high and she went back down to 3.5.No further complications were reported.

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 the changed the program and the frequency and has a follow up annual appointment on (b)(6) 2022.No further complications were reported/anticipated at this time.

• 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: 12463015
• MDR Text Key: 271129389
• Report Number: 3004209178-2021-13738
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Date Device Manufactured: 10/03/2019
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 77 KG