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); Insufficient Information (3190)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 08/21/2019

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 they therapy never helped with their symptoms.They further stated that it was disappointing as she is leaking and using 2 pads at night.During the call, it was determined that the patient is at 1.2 v in p 6.Patient increased to 1.4 v on the call and says she feels a little stimulation.It was reviewed how to use equipment, reviewed to monitor symptoms and follow up with hcp is therapy still not helping.Additional information was received.The patient's reason for calling was for assistance with making changes to therapy to help reduce symptoms.They stated their current settings were not working, they had to change pads even during the night.They stated the therapy helped for a little while, then it stopped.Patient could not confirm if this was sudden or gradual.They stated they had made an adjustment on (b)(6) 2019, but it was not helping.They tried calling their healthcare provider, but could not get ahold of anyone.They were able to sync with their patient programmer on the call, it showed stimulation was on.Patient was walked through increasing program 6 from 2.2 to 2.6, then back down to 2.4 where the patient confirmed comfortable stimulation in the correct area.Patient was going to monitor symptoms and follow-up with their healthcare provider if they didn't resolve.It was noted they had an appointment scheduled with their healthcare provider in a month.Additional information was received.It was reported that they do not feel that their device is working.They started on program 6 at 1.3 and initially was receiving relief, but now they are getting up at least 6 times during the night and changing pads regularly.They normally can make it through the night, but now in the morning it is soaked with urine.Patient stated that they have adjusted stimulation but have not changed programs.They stated that they were increasing, sometimes up to 8, and still felt no stimulation.Patient services walked through troubleshooting with the patient, and the patient said they would try different programs.Patient was redirected to their hcp and rep for program adjustments and to have the device checked.It was reported that this device does not work as well as the first device.

Manufacturer Narrative

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

Event Description

Follow up information received from the patient reported that the device had not worked well since it was implanted.As steps taken to resolve the issue, the doctor was having the patient do exercises to strengthen the muscles for urination.The patient also mentioned that they increased ¿volume¿ which had helped.The patient indicated that their doctor does everything possible to ¿help in every way¿.They were going to continue what they were doing and were to go back to their doctor in about 2 months.There were no further complications reported or anticipated.

• 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: 9350181
• MDR Text Key: 176235248
• Report Number: 3004209178-2019-22249
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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
• Date Manufacturer Received: 12/30/2019
• Date Device Manufactured: 07/01/2019
• 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: 85 YR