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

Model Number 3058

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275); Sleep Dysfunction (2517)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.Patient reported that since implant she has some good days and some bad days and stated that she does seem to have more sense on when she need to get to the bathroom but yesterday she went peeing quite often.No further complications were reported or anticipated.Additional information was received from the consumer.It was reported that they have gotten progressively worse and it is like nothing ever happened.They can't sleep at night because they will just pee their pants or wake up multiple times a night.They were told to increase stimulation a few times per year, but they had not done that at all.Additional information was received.They emotionally couldn't handle not resting at night due to their overactive bladder.They have been getting up at least six times per night and is wetting their pajamas in the process of getting to the restroom.They stated that the implant had not worked since implant and wants to talk to their hcp about the issue.They successfully charged the external equipment and connected to therapy settings.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.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider (hcp).In response to the inquiry if the cause of the device not working had been determined the hcp replied ¿no.¿ in response to the inquiry for what actions/interventions had been taken to resolve the device not working the hcp replied on (b)(6) 2020 the amplitude was increased to 1.5 and in response to the inquiry of what other actions had been taken if the device not working hadn¿t been resolved the hcp replied that on (b)(6) 2020 that the patient reported that they had no problems.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider (hcp) stated that patient never reported the issue of device not working.Hcp stated that device is in place, working well for the patient and she desires to continue use at the current setting.Stimulation was on and patient was feeling comfortable stimulation at the bike seat area.Patient denies dysuria, frequency, and urgency.Patient stated relief of symptoms since the last visit.Patient to return to clinic in 6 months or earlier if needed.

• 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: 9615788
• MDR Text Key: 176125434
• Report Number: 3004209178-2020-01533
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2020

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: 11/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/29/2020; 02/26/2020; 03/20/2020
• Supplement Dates FDA Received: 02/25/2020; 02/26/2020; 04/08/2020
• Date Device Manufactured: 05/21/2019
• 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 Age: 80 YR
• Patient Weight: 103