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); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119); Electric Shock (2554); Hematuria (2558); Constipation (3274); Insufficient Information (4580)

Event Date 02/28/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor and fecal incontinence.It was reported that patient said she had back surgery on (b)(6) 2023, she had cracks in two places in her back.Patient has problems with her neck and upper back.She was leaning over 13 cm slip disk.They put it back to 7 cm.When they went in to do the surgery it seemed like the battery had moved sideways more towards the center and it's out of its little pocket.Patient needs some mri's of her back and neck.She is looking for a doctor in the area that works with the devices.They were going to put a pain stimulator in there but it was slipped so far they couldn't.They did a x ray to find what they needed to find.Right now her bowel is impacted, and it's not working.It isn't letting anything out.In the middle of the skin she can feel it bulging.She can feel the poop above the rectum.They sent her home with a catheter after the back surgery and she was on that for two weeks and she was getting a lot of blood in her urine.She said, after she came out of surgery she can't feel herself pee and she is wearing a diaper.The doctor said it was just a thin roll of tissue keeping it separated from the valve.They replaced the catheter at home about five times.On the 12th day she said she would have to pay someone to walk in and rip it out.She did it herself.Patient went to the neurologist and they were supposed to get back to her with someone that might be able to do it.The pain in her back she doesn't think is related to the stimulator, but she has been getting electric shocks down her right leg like you scream.It goes away, it has happened just a few times.The issue was not resolved through troubleshooting.Sent patient doctor listings.Patient mentioned the moving people had her equipment in the truck for 90 days.

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed 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

Additional information was received from the patient.They repeated that the device slipped on the pocket and it hurt.Patient requested physician listings.Patient also said will be having mri of head and asked for review on how to turn therapy off.Patient services reviewed mri information and basic functionality of the programmer.During call patient successfully practiced turning therapy off and on.Patient services emailed listings and programmer quick guide.Patient services redirected patient to consult with new managing physician regarding management of urinary issues in addition to bowel.

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.

• 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: 17407614
• MDR Text Key: 319883357
• Report Number: 3004209178-2023-13378
• 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,Followup
• Report Date: 10/18/2023

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: 12/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/18/2023
• Date Device Manufactured: 07/02/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female