MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631); Compatibility Problem (2960)

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

Event Type  Injury  

Manufacturer Narrative

Product id 3037, serial# (b)(4); product type programmer, patient product id 3889-28, lot# va080t8, implanted: 2013 (b)(6); product type lead product id 3037, serial# (b)(4); product type programmer, patient.(b)(4).

Event Description

It was reported that there was a loss of therapeutic effect and the therapy hadn't really worked for the patient very well.It was noted that the patient was still getting up three to four times a night and it still wasn't "doing its job".It was reported that maybe this was because of the prostate and the patient had been diagnosed with prostate cancer.The reporter stated that therapy did seem to be helping while the patient was driving and previously they had to stop every hour and now sometimes they could go two hours before stopping.It was reported that there was no stimulation sensation and the patient didn't feel stimulation anymore.It was noted that the therapy worked fairly well at first and then it didn't work as well.The patient had increased it to 4.It was reported that the loss of therapeutic effect had gone on for quite a while, for several months, and it had been since autumn.The reporter stated that at night the patient had three hours at most before he got up to use the bathroom.It was reported that at night the patient was not emptying his bladder, was in bed less than two minutes and it sounded like a fair amount and not a dribble.Additional information reported that the patient's trial worked but the permanent device had not worked well for them.The patient still got up 5 to 6 times per night and they were thinking about removing the device.It was reported that the therapy worked a little bit a month or two after implant.The patient had not felt stimulation in quite a while and had never turned it off.It was reported that the patient programmer screen would not light up.The batteries in the programmer were replaced.It was noted that stimulation was set at 4.1v.It was noted that the patient services representative heard the patient squeal as though receiving a shock.Stimulation was turned off and decreased to 2.1v before stimulation was turned back on and increased to a level that was comfortable with the patient.It was reported that the patient felt stimulation in their testicles.It was noted that in 5 days they would make the molds for the patient's legs and that they would do the x-rays because, they couldn't do the mri then the following week they would do the radiation.The indications for use were noted as urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.There were no further details, interventions or an outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5125195
• MDR Text Key: 27438313
• Report Number: 3004209178-2015-19910
• Device Sequence Number: 1
• Product Code: EZW
• 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: Patient Family Member or Friend
• Report Date: 01/21/2014

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: 07/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Date Device Manufactured: 02/13/2013
• 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: 00071 YR