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

Model Number 3058

Device Problems Unexpected Therapeutic Results (1631); Malposition of Device (2616)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

Event date is approximate.Concomitant medical products: product id: 3889-28, lot#: va1j88h, implanted: (b)(6) 2017, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 14-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient's trial worked better than their implant.Patient found a program that worked well, but stated that another one just burned.Patient mentioned they already tried all programs and increasing and decreasing.No further complications were reported.The patient later reported that he was reprogrammed because he was having issues with the programs not helping his symptoms and the new programs are still not great.Patient stated that "channel 1" was too soft, and "channel 2" stings.Patient wanted to set up meeting with representative and patient was directed to healthcare provider (hcp).Additional information reported that the setting #2 produced the burning pain as soon as it was used.The setting three was similar to #2 and needed adjusting also.The patient met with physician on (b)(6) 2018 and the parameters changed on the programs.Improvements noted.The patient was still tweaking stimulator to optimize sensation and results.The patient was planning on setting up another appointment to adjust settings 2 & 3, again, as they are still "sharp" in sensation.Additional information was received from the consumer.It was reported the patient saw their manufacturer representative about a month ago and stated the goal was to try and get the stimulation so that the patient did not feel it anymore.Patient reported the representative stated it would take about 3 months but that it ¿kind of¿ felt ¿the same as it has ,¿ and the patient was not sure what to do.The patient stated they did not think the stimulation had changed much.The patient confirmed that this was an uncomfortable stimulation.The patient reported there was a ¿fine line¿ between where it worked and where it was uncomfortable and they were trying to hit the ¿middle line.¿ the patient confirmed they tried all four programs.There were no further complications reported/anticipated.Additional information was received from the patient.The patient had their micro ins implanted.They reported that they were experiencing better symptom control sine receiving the newer system.They mentioned this to a manufacturing representative and they replied that it was because the new wire was placed in a better position.Additional information was received from a manufacturer representative (rep).The rep reported that the replacement had occurred due to the lead placement issue.The rep wrote that the patient had programming changes with their old lead and it had been revised.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10738206
• MDR Text Key: 213216092
• Report Number: 3004209178-2020-18713
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Date Device Manufactured: 08/31/2017
• 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: 52 YR