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

Model Number 3058

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Sleep Dysfunction (2517)

Event Date 05/29/2019

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 regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported by patient that since the past couple of weeks; (b)(6) 2019 patient has had a lot of leaking.Patient stated they will gush before they get to the toilet.Patient reported the morning of the report, their bed pad was wet.There were no falls or trauma.Patient stated it seemed like in the beginning it they were not leaking as much.Patient stated they had not made any changes to therapy.Patient was on program 4 at 1.1.During call, patient increased stim to 1.6 and was feeling comfortable stimulation.On (b)(6) 2019, additional information was received.Patient reported that they were trained under anesthesia.On (b)(6) 2019, additional information was received from the patient.The patient reported that she was leaking really bad.At night, the patient would get the urge to go and she couldn't even get out of the bed and she had already gone.The patient stated that she got on the toilet to finish her void and she only goes a little bit.The patient stated that she didn't feel she completely voids.The patient stated that she consistently wakes up at 2am and 4am.The patient stated that it was a gradual change in therapy and that this started a month or more ago.The patient was on program 4 at 2.9 volts and she increased the stim to 3.2 volts.The patient stated that stim was on, and they felt stimulation in the correct area (i.E.Bike seat).The patient was on program 4 and she increased it to 3.5 volts.The patient reviewed that it takes time for the body to respond to therapy, therefore titrations should be discussed with the healthcare provider (hcp).Patient services told the patient to consider completing voiding diary to track progression/therapeutic response.Patient services told the caller to give it a couple days and see if her symptoms get better.The patient stated that they did not intend to follow-up with any healthcare provider (hcp).No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient in response to an inquiry for more details regarding the event: when asked the cause of the retention, the patient replied that their device needed adjustment.Retention was not a pre-existing condition for the patient.No further complications were anticipated/reported.

• 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: 9199530
• MDR Text Key: 163000748
• Report Number: 3004209178-2019-19779
• 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: 12/12/2019

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: 04/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/12/2019
• Date Device Manufactured: 10/23/2018
• 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 Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 65