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

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Inadequate Instructions for Non-Healthcare Professional (2956); Data Problem (3196)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.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 stimulation and gastrointestinal/pelvic floor.It was reported that the patient had been trying to use the programmer and it hadn¿t been working properly for a couple of weeks.The patient stated they put the programmer on the implant and it went to 6.7 volts and they got a shock to the vaginal area and they were in pain for weeks.The patient then later stated they were on program 2 at 2.3 volts and the stimulation went up to 7.3 volts and really hurt, that was a couple of weeks ago.Syncing with the ins showed the stimulation was on at 2.3 volts on program 2.The patient kept pressing the navigation key and they would see the other programs: program 1 at 4.9 volts and program 3 at 6.1 volts.It was explained that they weren¿t actually on the program if they didn¿t have a check mark, and the ones without check marks are just other options they would change to.The patient increased to 2.4 volts while on the call and stated it was comfortable.The patient was advised to stay on that setting for a couple of days and see if they got relief, and to decrease stimulation if it gets uncomfortable.It was noted that the patient received inadequate training.No further complications were reported.

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 there were no circumstances that led to the issue.As a step taken to resolve the issue, the patient stated ¿a new program of 2:30?¿.They mentioned that, overall, they were not satisfied with the manufacturer¿s product as they got little bladder relief since it ¿has been inserted¿.The patient indicate that they had ¿no backup¿ from their urologist (¿had enough and being on the phone to supervise #¿s¿).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: 9070032
• MDR Text Key: 164610372
• Report Number: 3004209178-2019-17682
• 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: 11/25/2019

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: 12/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/25/2019
• Date Device Manufactured: 06/21/2017
• 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 Age: 77 YR
• Patient Weight: 57