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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Therapeutic Response, Decreased (2271)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member of a consumer with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient drank close to 100 oz of water yesterday and could not push it out.The patient told the caller that this had been going on for about two months.The patient feels the pressure to urinate but cannot go.They feel a lot of pain at the site of the stimulator and where she feels the zap where it makes it work she doesn't feel the zap anymore.The patient won't urinate hardly throughout the day.In the evening the patient can go every hour or two hours until morning.The patient can urinate at night but not a whole lot.During the day it won't come out.The hcp recommended calling patient services.The device shows stim is on, program 2 at 2.7v.Patient increased stim to 3.0, patient could feel stim.Reviewed therapy expectations titrations, recommended a voiding diary.Patient had the surgery with the mesh and still wasn't emptying so the patient had interstim trial and it worked.Caller reported no falls or accidents are related to this issue.Patient has a hcp appointment scheduled for the next month.The caller stated that they took the patient to see the hcp and rep 4 months ago and the patient was still not emptying all the way but they could empty.The caller had increased the patient's stim a lot and the rep had them take it back down.Caller said there was not an issue at that time.Additional information was received from the friend/family member.The caller stated that the patient was brought to the nursing home and has a catheter in them because the patient is not feeling any stimulation at all.The caller was wondering what settings it should be on.Patient services redirected the caller to the hcp's instructions.The caller adjusted stim to program 3 at 3.4v and will monitor the patient's symptoms.No further device issue alleged / identified.No further patient symptoms or complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) in response to an inquiry for more details regarding the event: patient weight was unknown.The cause of not feeling stimulation was not determined.The patient was diagnosed with retention, that was why she was trialing the device.The patient was implanted (b)(6) 2019 and no other actions were taken.Hcp stated the retention resolved.No further patient symptoms or complications were reported.

Manufacturer Narrative

(b)(4).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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9362138
• MDR Text Key: 167654475
• Report Number: 3004209178-2019-22393
• 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,Followup
• Report Date: 12/13/2019

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: 07/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 12/13/2019; 12/13/2019
• Supplement Dates FDA Received: 12/13/2019; 12/13/2019
• Date Device Manufactured: 02/04/2019
• 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): Required Intervention
• Patient Age: 80 YR